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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 K141721
Device Name BOVINE PERICARDIUM PATCH
Applicant
COLLAFIRM LLC
7 Deer Park Drive
Suite M-7
Monmouth Jct,  NJ  08852
Applicant Contact Surendra P Batra
Correspondent
COLLAFIRM LLC
7 Deer Park Drive
Suite M-7
Monmouth Jct,  NJ  08852
Correspondent Contact Surendra P Batra
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OXB   OXE   PAJ  
Date Received06/25/2014
Decision Date 12/22/2014
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
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