CYTORI PUREGRAFT 250/PURE 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 Cytori Puregraft 250/pure System.

Pre-market Notification Details

Device IDK092923
510k NumberK092923
Device Name:CYTORI PUREGRAFT 250/PURE 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 Received2009-09-23
Decision Date2010-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20863445000301 K092923 000
10860407002215 K092923 000
00850034511245 K092923 000
00850034511146 K092923 000

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