The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Cytori Celution Cell Concentration Device.
| Device ID | K060482 |
| 510k Number | K060482 |
| Device Name: | CYTORI CELUTION CELL CONCENTRATION DEVICE |
| Classification | Apparatus, Autotransfusion |
| 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 | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-23 |
| Decision Date | 2006-09-28 |
| Summary: | summary |