The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Cytori Puregraft 250/pure System.
Device ID | K092923 |
510k Number | K092923 |
Device Name: | CYTORI PUREGRAFT 250/PURE SYSTEM |
Classification | System, Suction, Lipoplasty |
Applicant | CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego, CA 92121 -1109 |
Contact | Kenneth K Kleinhenz |
Correspondent | Kenneth K Kleinhenz CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego, CA 92121 -1109 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-23 |
Decision Date | 2010-01-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20863445000301 | K092923 | 000 |
10860407002215 | K092923 | 000 |
00850034511245 | K092923 | 000 |
00850034511146 | K092923 | 000 |