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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)
Number
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Decision
Date
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rx everest JENERIC/PENTRON, INC. k001051 04/28/2000
model 120 PALCO LABS, INC. k994372 04/28/2000
cedia dau amphassure assay MICROGENICS CORP. k994380 05/02/2000
multi lumen suction syringe spray dispenser BIOSURGICAL CORP. k000438 05/03/2000
agilent information center software for m3150a and m3153a and agilent m2/m3/m4 compact portable patient monitor AGILENT TECHNOLOGIES, INC. k001057 05/03/2000
kavo k.e.y. laser 1242 KAVO AMERICA k000805 05/04/2000
sharp brand acupuncture needles TCM SUPPLY CORP. k000816 05/04/2000
directflow kit, 24 fr, softclamp kit, 24fr, straightshot kit, 23 fr, straight tip, straightshot kit, 23 fr, angled tip HEARTPORT, INC. k994243 05/05/2000
connect data management system ABBOTT DIABETES CARE INC. k994433 05/05/2000
transpak (vitreoretinal infusion pak), models 90000, 90001 RETINALABS.COM k000416 05/08/2000

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