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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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Applicant
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510(K)
Number
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Decision
Date
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advia centaur homocysteine assay BAYER DIAGNOSTICS CORP. k013406 12/18/2001
advia testpoint csf control BAYER DIAGNOSTICS CORP. k022968 09/24/2002
aequalis shoulder fracture system TORNIER k994392 03/10/2000
aequalis universal shoulder glenoid TORNIER k994393 06/22/2000
aerovent ii chc collapsible holding chamber MONAGHAN MEDICAL CORP. k012939 09/28/2001
afb (absorbable foam buttress) J&J CORPORATE BIOMATERIALS CENTER k014183 06/12/2002
agiltrac .018 peripheral dilatation catheter GUIDANT CORP. k020161 02/22/2002
airis ii HITACHI MEDICAL SYSTEMS AMERICA, INC. k994378 03/07/2000
allergen immunocap, models c74, e89, ex2, ex70, ex71, ex73, fx8, fx9, fx10, fx16, fx73, i72, i75, i76, k71, k73, k81, k8 PHARMACIA & UPJOHN CO. k000132 02/18/2000
alpha drive system ALPHA OMEGA LTD. k013396 08/07/2002

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