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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 K170348
Device Name Signia Four-Bay Smart Charger (to be used with Signia Stapler)
60 Middletown Avenue
North Haven,  CT  06473
Applicant Contact Katherine Y. Choi
60 Middletown Avenue
North Haven,  CT  06473
Correspondent Contact Katherine Y. Choi
Regulation Number878.4750
Classification Product Code
Date Received02/03/2017
Decision Date 03/02/2017
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