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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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davol absorbable fastener system, model (s) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 C.R. BARD, INC. k082396 01/02/2009
tempusic patient monitor REMOTE DIAGNOSTIC TECHNOLOGIES LTD. k082718 10/10/2008
model r605dasm automatic x-ray collimator RALCO S.R.L. k083029 12/05/2008
precision endoscopic infrared coagulator; model 5100 single- use disposable maxi-guide flexible lightguide; model 5100-2 MAX ENDOSCOPY INC. k083275 06/09/2009
cliniqa liquidqc immunoassay control level 1, 2 & 3 CLINIQA CORPORATION k083554 04/21/2009
neurometrix advance NEUROMETRIX, INC. k070109 04/25/2008
urostym biofeedback and stimulation device and accessories LABORIE MEDICAL TECHNOLOGIES k070331 05/04/2007
philips suresigns vsv (vital signs viewer) PHILIPS MEDICAL SYSTEMS k070588 03/20/2007
sis facial cylinder, sis facial implant COOK BIOTECH, INC. k070738 04/05/2007
rii infrared ear thermometer, model th01bn RADIANT INNOVATION INC. k070976 04/20/2007

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