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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 K162617
Device Name NobleStitch EL
Applicant
NOBLES MEDICAL TECHNOLOGIES II, INC.
17074 NEWHOPE ST.
FOUNTAIN VALLEY,  CA  92708
Applicant Contact FAYE DUNN
Correspondent
NOBLES MEDICAL TECHNOLOGIES II, INC.
17074 NEWHOPE ST.
FOUNTAIN VALLEY,  CA  92708
Correspondent Contact Jason Lyon
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
GAT  
Date Received09/20/2016
Decision Date 04/06/2017
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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