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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K160969
Device Name ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
Applicant
SHINEMED LLC
7200 ALOMA AVE.,
WINTER PARK,  FL  32792
Applicant Contact ROGELIO A. INSIGNARES
Correspondent
SHINEMED LLC
7200 ALOMA AVE.,
WINTER PARK,  FL  32792
Correspondent Contact ROGELIO A. INSIGNARES
Regulation Number878.4750
Classification Product Code
GDW  
Date Received04/06/2016
Decision Date 12/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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