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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
Applicant
NOBLES MEDICAL TECHNOLOGIES II, INC.
17080 Newhope St
Fountain Valley,  CA  92708
Applicant Contact MARIA HATEGAN
Correspondent
NOBLES MEDICAL TECHNOLOGIES II, INC.
17080 Newhope St
Fountain Valley,  CA  92708
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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