FDA 510(k) K100261, PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD, by Tei Biosciences, Inc.
FDA 510(k) K100261, PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD, by Tei Biosciences, Inc.
Device Classification Name: Dressing, Wound, Drug
510(k) Number: K100261
Device Name: PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
Applicant: Tei Biosciences, Inc.
Regulation Number: nan
Classification Product Code: FRO
Date Received: 01/28/2010
Decision Date: 12/10/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: nan
510k Review Panel: General & Plastic Surgery
Total number of pages: 914
Fully redacted pages: 466
Content pages: 448
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