MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET

Mesh, Surgical, Polymeric

MACROPORE BIOSURGERY, INC.

The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Surgi-wrap Mast Bioresorbable Sheet.

Pre-market Notification Details

Device IDK031955
510k NumberK031955
Device Name:MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
ClassificationMesh, Surgical, Polymeric
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 CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-25
Decision Date2003-09-22
Summary:summary

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