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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
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self adhering navigus guide Image-Guided Neurologics, Inc. k001192 06/07/2000
cedia dau 6-acetylmorphine assay Microgenics Corp. k001178 06/09/2000
hi-res 9000 phased array carotid coil Usa Instruments, Inc. k001210 06/09/2000
polyester nonabsorbable surgical sutures urp Cp Medical k001172 06/23/2000
nylon, nonabsorbable surgical sutures usp Cp Medical k001173 06/23/2000
silk, nonabsorbable, surgical sutures, usp Cp Medical k001184 06/23/2000
polypropylene, nonabsorbable surgical sutures usp Cp Medical k001185 06/23/2000
modification to nc-stat Neurometrix, Inc. k000565 06/27/2000
temporary pacemaker extension cable, models 5235, 5235a, 5235v, temporary pacemaker surgical extension cable, models 528 Pace Medical k001180 06/27/2000
bioscanner triglycerides test strips Polymer Technology Systems, Inc. k000586 07/03/2000

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