PRIMATRIX DERMAL REPAIR SCAFFOLD

Dressing, Wound, Collagen

TEI BIOSCIENCES INC.

The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Primatrix Dermal Repair Scaffold.

Pre-market Notification Details

Device IDK131286
510k NumberK131286
Device Name:PRIMATRIX DERMAL REPAIR SCAFFOLD
ClassificationDressing, Wound, Collagen
Applicant TEI BIOSCIENCES INC. 7 ELKINS ST. Boston,  MA  02127
ContactKenneth James
CorrespondentKenneth James
TEI BIOSCIENCES INC. 7 ELKINS ST. Boston,  MA  02127
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-06
Decision Date2013-08-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10381780113317 K131286 000

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