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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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510(K)
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bond 1 c & b JENERIC/PENTRON, INC. k994359 03/21/2000
boston xo (hexafocon a), boston eo (enflufocon b) and boston es (enflufocon a) rigid gas permeable contact lenses BAUSCH & LOMB, INC. k071043 08/02/2007
brainscan BRAINLAB AG k994413 07/13/2000
breast pump Guangzhou Jinxinbao Electronic Co.,Ltd k150923 11/06/2015
breath alcohol test system, model al-5000 SENTECH KOREA CORP. k061922 10/30/2006
buprenorphine enzyme immunoassay, calibrators and controls for beckman coulter synchron systems Lin-Zhi International, Inc. k081008 12/22/2008
bwf-5 medical laser series, 810 nm; 930 nm; 980 nm; 1080 nm B&W TEK, INC. k062363 01/17/2007
candela gentlelase family of laser systems CANDELA CORP. k024260 03/21/2003
candela gentlelase gl dermatological laser CANDELA CORP. k994260 05/26/2000
cardeon aegis catheter CARDEON CORP. k013593 06/24/2002

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