The following data is part of a premarket notification filed by Primaeva Medical, Inc. with the FDA for Primaeva Medical System.
| Device ID | K080145 |
| 510k Number | K080145 |
| Device Name: | PRIMAEVA MEDICAL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | PRIMAEVA MEDICAL, INC. 42840 CHRISTY STREET SUITE 101 Fremont, CA 94538 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby PRIMAEVA MEDICAL, INC. 42840 CHRISTY STREET SUITE 101 Fremont, CA 94538 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-22 |
| Decision Date | 2008-02-28 |
| Summary: | summary |