MACROPORE SURGICAL BARRIER FILM

Wrap, Implant, Orbital

MACROPORE BIOSURGERY, INC.

The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Surgical Barrier Film.

Pre-market Notification Details

Device IDK023643
510k NumberK023643
Device Name:MACROPORE SURGICAL BARRIER FILM
ClassificationWrap, Implant, Orbital
Applicant MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
ContactKenneth K Kleinhenz
CorrespondentKenneth K Kleinhenz
MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego,  CA  92121
Product CodeMTZ  
CFR Regulation Number886.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-30
Decision Date2003-02-21
Summary:summary

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