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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 K140533
Device Name GALAFLEX MESH
Applicant
Tepha, Inc.
99 Hayden, Sutie 360
Lexington,  MA  02421
Applicant Contact MARY P LEGRAW
Correspondent
Tepha, Inc.
99 Hayden, Sutie 360
Lexington,  MA  02421
Correspondent Contact MARY P LEGRAW
Regulation Number878.3300
Classification Product Code
OOD  
Date Received03/04/2014
Decision Date 05/21/2014
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
Predetermined Change
Control Plan Authorized		 No
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