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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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Decision
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perfadex solution for organ preservation VITROLIFE SWEDEN AB k000881 03/08/2001
intuitive surgical da vinci endoscopic control system INTUITIVE SURGICAL, INC. k002489 03/02/2001
maeda new needle disposable MAEDA TOYOKICHI SHOTEN k000581 02/23/2001
z-touch BRAINLAB, AG k003268 02/22/2001
x-sept transseptal sheath and transition catheter, model mv-03-09-90, mv-03-10-90, mv-03-11-90, mv-03-09-120, mv-03-10-1 APPRIVA MEDICAL, INC. k002054 02/16/2001
a & i wheelchairs TAIWAN AN I CO.,LTD. k010094 02/15/2001
org-9200a NIHON KOHDEN AMERICA, INC. k002068 02/08/2001
pva foam embolization particles SURGICA CORP. k001678 01/25/2001
bd probetec et mycobacterium tuberculosis complex (ctb) culture identification assay BECTON DICKINSON BIOSCIENCES k000884 01/19/2001
a&d medical tm-2550/tm-2551/tm-2560 vital sensor monitor A & D ENGINEERING, INC. k002061 01/19/2001

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