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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K083440
Device Name PRIMATRIX DERMAL REPAIR SCAFFOLD
Applicant
Tei Biosciences, Inc.
7 Elkins St.
Boston,  MA  02127
Applicant Contact KENNETH JAMES
Correspondent
Tei Biosciences, Inc.
7 Elkins St.
Boston,  MA  02127
Correspondent Contact KENNETH JAMES
Classification Product Code
KGN  
Date Received11/20/2008
Decision Date 12/12/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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