The following data is part of a premarket notification filed by Primaeva Medical, Inc. with the FDA for Primaeva Medical Renesis System.
| Device ID | K082391 |
| 510k Number | K082391 |
| Device Name: | PRIMAEVA MEDICAL RENESIS SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PRIMAEVA MEDICAL, INC. 4160 HACIENDA DR., SUITE 100 Pleasanton, CA 94588 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby PRIMAEVA MEDICAL, INC. 4160 HACIENDA DR., SUITE 100 Pleasanton, CA 94588 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-19 |
| Decision Date | 2009-09-01 |
| Summary: | summary |