TUTOPLAST DURA

Human Lyophilized Dura Mater

PFRIMMER-VIGGO GMBH & CO.

The following data is part of a premarket notification filed by Pfrimmer-viggo Gmbh & Co. with the FDA for Tutoplast Dura.

Pre-market Notification Details

Device IDK910555
510k NumberK910555
Device Name:TUTOPLAST DURA
ClassificationHuman Lyophilized Dura Mater
Applicant PFRIMMER-VIGGO GMBH & CO. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N. W. Washington,  DC  20036
ContactAlan H Kaplan
CorrespondentAlan H Kaplan
PFRIMMER-VIGGO GMBH & CO. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N. W. Washington,  DC  20036
Product CodeLEM  
CFR Regulation Number882.5975 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-07
Decision Date1992-04-20

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