MACROPORE PURICEL LIPOPLASTY SYSTEM

System, Suction, Lipoplasty

MACROPORE BIOSURGERY, INC.

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

Pre-market Notification Details

Device IDK042261
510k NumberK042261
Device Name:MACROPORE PURICEL LIPOPLASTY SYSTEM
ClassificationSystem, Suction, Lipoplasty
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 CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-23
Decision Date2004-09-20
Summary:summary

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