MACROPORE OS RECONSTRUCTION

Mesh, Surgical, Metal

MACROPORE BIOSURGERY, INC.

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

Pre-market Notification Details

Device IDK024169
510k NumberK024169
Device Name:MACROPORE OS RECONSTRUCTION
ClassificationMesh, Surgical, Metal
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 CodeEZX  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
Subsequent Product CodeMAI
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-18
Decision Date2003-07-01
Summary:summary

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