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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K113763
Device Name SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
Original Applicant
NOBLES MEDICAL TECHNOLOGIES II, INC.
17080 newhope st
fountain valley,  CA  92708
Original Contact maria hategan
Regulation Number878.5010
Classification Product Code
GAW  
Date Received12/21/2011
Decision Date 03/16/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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