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U.S. Department of Health and Human Services

510(K) Premarket Notification

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261 to 270 of 500 Results *
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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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cosmed quark COSMED S.R.L. k001174 01/11/2001
seragard vascular access patch PLATINUM SERVICES, INC. k001175 09/18/2000
disposable microkeratome blades-pe OASIS MEDICAL, INC. k001176 09/21/2000
pp-cap eia for the detection of iga antibodies to h. pylori ENTERIC PRODUCTS, INC. k001177 11/13/2000
cedia dau 6-acetylmorphine assay MICROGENICS CORP. k001178 06/09/2000
super nova, acubeam LIGHT FORCE THERAPY, INC. k001179 10/27/2000
temporary pacemaker extension cable, models 5235, 5235a, 5235v, temporary pacemaker surgical extension cable, models 528 PACE MEDICAL k001180 06/27/2000
microlife wrist watch blood pressure monitor, model bp-3bu1 MICROLIFE CORP. k001182 08/01/2000
sigma diagnostics infinity glucose reagent, models 17-25, 17-100p, 17-500p, 17-2000p, 18-20, 18-100p SIGMA DIAGNOSTICS, INC. k001403 08/10/2000
gold total and partial, regular and offset, ossicular replacement prostheses, gold total with fountian head, gold piston MEDNET LOCATOR, INC. k001404 08/08/2000

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