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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K162965
Device Name SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
Applicant
Tei Biosciences, Inc.
7 Elkins St.
Boston,  MA  02127
Applicant Contact Kavita Amin
Correspondent
Integra Lifesciences Corporation (Owner of Tei Biosciences)
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact Kavita Amin
Regulation Number878.3300
Classification Product Code
FTM  
Date Received10/24/2016
Decision Date 02/16/2017
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
Recalls CDRH Recalls
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