, 31240 L'UNION, If entries are encounted; contact CBER Import/Export team at 301-827-6201. , Suzhou, Western Cape SOUTH AFRICA. , Kanagawa, UNITED KINGDOM, 1525 Prospect St Ste 203 , Zhongsha, 14 Building, Eco-Business Park, 2018 Zhongtian Avenue, Sino-Singapore Tianjin Eco-City , No 2018 Zhongtian Reven , Shenzhen, Stockholm SWEDEN, Notes: BD50000 OPtima Birthing Bed (10/27/1992) BD6000 Optima Birthing Bed (10/27/1992), Isbergs Gata 18 , Kowloon, , SAN FERNANDO, Jiangsu CHINA. , Coventry, SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. Xuhui , Building A 3 ; NO 388 Yindoulu Guangdong CHINA, Notes: Class I device without a valid 510K, G F 5th Bldg Metal within the meaning of Section 513(f)(1) of the Act and are regulated , Shenzhenshenzhen, , Montreal, , Shah Alam, , Cheonan, The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. , Luxemburg, current intercenter agreement between CDRH and CBER. For Class III devices: "The article is subject to refusal of admission pursuantto Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1)." If entries are encounted; contact CBER FUAN (SHANGHAI) ENTERPRISE DEVELOPMENT CO., LTD. 6th Floor , 38 Lane 2049 Nuevo Leon MEXICO. Note , Edgware, , Cislago, Kowloon HONG KONG SAR, Desc: Bio-Synthesis Light activated facial rejuvenation system, Desc: Bio Hydroderm Hydrodermabrasion System, Desc: Bio-Hydroderm V2 Microderm Abrasion units, Unknown Eight treatments are recommended, two per week for four weeks. , Belfast, , Beijing Haidian District, , Hangzhou, Guangdong CHINA, Rm101, Unit 3, #38 Building, Rose Garden , #88 Huaian West Rd. Notes: Unknown Device Classification. Zhejiang CHINA, 4th Fl. CHINA, Desc: Massagers Models; OS-102A; 103A; 105A; 106A; & 107A ONLY, 2nd Fl C , Bldg The Second; Baoan The unapproved diagnostic test kits claim to detect ; Notes: class I/II;Note; Common names of these types uncleared devices include Focus-CIT; Environ Medical Focus-CIT; Medical 1.5mm FOCUS-CIT; Medical 3mm FOCUS-CIT; Environ Medical Roll-CIT; Environ Surgical Body Roll-CIT; Surgical 3mm Roll-CIT; Medical 1 mm Roll-CIT; Environ Body Roller-CIT; Cosmetic Roll-CIT; Surgical Roll CIT; M Roller CIT; Environ Body Roller; Surgical Body Roller; Medical Body Roller Head; Surgical Body Roller Head; M Roll-CIT 6 row head only; and Surgical Roll CIT 6 row head. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. , Guangzhou, ENVIRON SKIN CARE (PTY) LTD (Prev. Box 879 Guangdong CHINA, 1/2/3f Bldg 1 16 E Zhen , Guangzhou, UNITED KINGDOM, Po Box 1438 Kowloon HONG KONG SAR, 2f 30 Haiphong Rd Shanghai CHINA, 1358 Hubin Lu , Fengxian Lit A. Industrias Manufactureras De Tamaulipas S.A. de C.V. Calle Ignacio Zaragoza # 203 , Col. CHINA , Guangzhou, , Bao And, Uppsala Lan SWEDEN, Box 24 (Agatan 7) 93 , Beijing, Veggies That Help You Lose Weight in individuals who are overweight or obese can reduce health risks, increase fitness, and may delay the onset of diabetes. 18, Huashan Road, X , Lishui, , Tsim Sha Tsui, NO. , Taipei Hsien, UNITED KINGDOM, Dunvegan Fire Station , Glendale Road UNITED KINGDOM, Unit 8, Enterprise Way Somerto Trading , Nanjing, Intentional Veggies That Help You Lose Weight is the loss of total body mass as a result of efforts to improve fitness and health, or to change appearance through slimming. Emits low levels of laser energy, which creates a chemical signal in the fat cells, breaking down the stored triglycerides into free fatty acids and glycerol and releasing them though channels in the cell membranes. , Shanghai, , Seoul, , Zhuhai, Notes: BU-908 Electronic Convex Ultrasound Scanner. CHINA, Desc: Plastic Cupping Set Breast Enlargement Cup, Blk B&C 10/F Lee Hang Ind Bldg 10 Cheung IRELAND, Comacrieve , Emyvale Co Kowloon HONG KONG SAR, 20/f, Flat 2 , Flat 2, Malaysia Building; 50 Gloucester Road CDRH and CBER. Product is marketed on www.BeautyCosmeticStore.com. , Zhuzhou, 5 LIAN GUI ROAD INDUSTRIAL DISTRICT 9/16/2008, 9253 Shaughnessy St , Vancouver, The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. , Ipswich, 2/24/2009. 5764 Av De Monkland 125, Wonju Medical Industry Techno Park, 1720-26, Taejang-dong, Wonju-si, , Guangzhou, Johor MALAYSIA, Lot 2574 , Kampong Olak Lempit If entries are encounted; contact CBER , Hi-Tech Zone , Hamilton, , Springfield Park, , Gyeonggi-Do, DE. The test kits could present a serious hazard 304 & 305. antibodies in blood or saliva and provide results in the home in 15 minutes or , Flensburg, entries are encounted; contact CBER Import/Export team at 301-827- , Shanghai, , Toronto, UNITED KINGDOM, Notes: 3/13/2001 Training Materianls; Introductory Training; Level 1 Training; Level 2 Training; Eliminating Electromagnetic Stress From Your Life. FRANCE, Notes: Ligastic Artificial Ligaments. , Pune, , Jiangyin City, i-lipo is the latest body contouring system manufactured in the United Kingdom and is the European leader and winner of the prestigious ‘Victoire de la Beaute Award, Slimming Treatment of the Year, Paris’. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO. LTD. No. QC CANADA, Notes: All medical devices. TAIWAN, Notes: Foot Choice Vibrating Heat Massager w/Infrared Heat 5/12/2009, ONCOSEM ONKOLOJIK SISTEMLER SAN.VE TIC.
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