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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name surgical film
510(k) Number K161092
Device Name GalaSHAPE 3D
Applicant
Tepha, Inc.
99 Hayden Avenue
Lexington,  MA  02421
Applicant Contact Connie H Garrison
Correspondent
Tepha, Inc.
99 Hayden Avenue
Lexington,  MA  02421
Correspondent Contact Connie H Garrison
Regulation Number878.3300
Classification Product Code
OOD  
Date Received04/18/2016
Decision Date 08/23/2016
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
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