PUREGRAFT 50 SYSTEM

System, Suction, Lipoplasty

CYTORI THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Puregraft 50 System.

Pre-market Notification Details

Device IDK132815
510k NumberK132815
Device Name:PUREGRAFT 50 SYSTEM
ClassificationSystem, Suction, Lipoplasty
Applicant CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego,  CA  92121 -1109
ContactKenneth K Kleinhenz
CorrespondentKenneth K Kleinhenz
CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego,  CA  92121 -1109
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-09
Decision Date2014-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00863445000345 K132815 000

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