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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
510(k) Number K082079
Device Name REGEN COLLAGEN SCAFFOLD (CS)
Applicant
Regen Biologics, Inc.
411 Hackensack Ave.
Hackensack,  NJ  07601
Applicant Contact JOHN DICHIARA
Correspondent
Regen Biologics, Inc.
411 Hackensack Ave.
Hackensack,  NJ  07601
Correspondent Contact JOHN DICHIARA
Regulation Number878.3300
Classification Product Code
OLC  
Date Received07/23/2008
Decision Date 12/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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