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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 K160176
Device Name Signia Stapler
60 Middletown Avenue
North Haven,  CT  06471
Applicant Contact Frank Gianelli
60 Middletown Avenue
North Haven,  CT  06471
Correspondent Contact Frank Gianelli
Regulation Number878.4750
Classification Product Code
Date Received01/27/2016
Decision Date 04/26/2016
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
Recalls CDRH Recalls