MACROPORE FX, PS, NS, LP

Plate, Bone

MACROPORE BIOSURGERY, INC.

The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Fx, Ps, Ns, Lp.

Pre-market Notification Details

Device IDK012413
510k NumberK012413
Device Name:MACROPORE FX, PS, NS, LP
ClassificationPlate, Bone
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 CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-30
Decision Date2001-09-18
Summary:summary

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