The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Puregraft 50 System.
| Device ID | K132815 |
| 510k Number | K132815 |
| Device Name: | PUREGRAFT 50 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 | 2013-09-09 |
| Decision Date | 2014-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863445000345 | K132815 | 000 |