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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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signa artist Ge Healthcare (Tianjin) Company Limited k202238 09/04/2020
gc fujicem GC America, Inc. k001730 07/17/2000
fusion putty type GC America, Inc. k043493 03/04/2005
unifast iii GC America, Inc. k073106 04/11/2008
gamcath high flow dolphin ms-gdhc-1315 a; and ms-gdhc-1315j a, gamcath high flow dolphin ms-gdhc-1320 a; and ms-gdhc-132 Gambro Renal Products, Inc. k100451 12/21/2010
diaclear ultrafilter Gambro Renal Products k003957 11/01/2001
synapse 3d blood flow analysis Fujifilm Corporation k191544 10/18/2019
algs2 ag alginate wound dressing rx; algs2 ag alginate wound dressing otc; algs2s re-enforced ag alginate wound dressing rx; algs2s re-enforced ag alginate wound dressing otc Foshan United Medical Technologies, Ltd. k233111 05/24/2024
sato family first aid kit Food and Drug Service, Inc. k831706 06/24/1983
indomitable magnetic resonance imaging scanner Fonar Corp. k002490 10/03/2000

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