The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Puregraft 850/pure System.
| Device ID | K113255 |
| 510k Number | K113255 |
| Device Name: | PUREGRAFT 850/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 | 2011-11-03 |
| Decision Date | 2012-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10863445000311 | K113255 | 000 |
| 10860407002222 | K113255 | 000 |
| 00850034511207 | K113255 | 000 |