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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 K113494
Model 12-90-07 12-25-11 18-20-11
Device Name NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
Applicant
NOBLES MEDICAL TECHNOLOGIES II, INC.
17080 newhope st
fountain valley,  CA  92708
Contact maria hategan
Regulation Number878.5010
Classification Product Code
GAW  
Date Received11/25/2011
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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