LYOPLANT DURA SUBSTITUTE(VARIOUS)

Dura Substitute

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Lyoplant Dura Substitute(various).

Pre-market Notification Details

Device IDK970851
510k NumberK970851
Device Name:LYOPLANT DURA SUBSTITUTE(VARIOUS)
ClassificationDura Substitute
Applicant AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco,  CA  94080
ContactVictoria Mackinnon
CorrespondentVictoria Mackinnon
AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco,  CA  94080
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-07
Decision Date1997-12-09
Summary:summary

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