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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
Date
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synthes (usa) resorbable tack system Synthes (Usa) k000560 01/09/2001
venodyne dvt advantage model 610 Microtek Medical, Inc. k001802 01/09/2001
kelo-cote topical gel Advanced Bio-Technologies, Inc. k002488 01/05/2001
bardex latex-free temperature-sensing foley catheter (uncoated); bardex lubri-sil temperature-sensing foley catheter (lu C.R. Bard, Inc. k003289 01/05/2001
260 corvus Pie Medical k003292 01/05/2001
astra tech implants - dental system Astra Tech, Inc. k002513 01/04/2001
surgisis peripheral vascular patch Cook Biotech, Inc. k001785 12/27/2000
pediatric ingestascan Adams Electronics, Inc. k003305 12/22/2000
surgassist system with circular stapler disposable loading unit, model cs21,cs25,cs29,cs33 Powermed, Inc. k003277 12/21/2000
variant ii total ghb Bio-Rad k003280 12/19/2000

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