The following data is part of a premarket notification filed by Cosman Medical, Inc. with the FDA for Cosman G4 Radiofrequency Generator, Model Rfg-4.
| Device ID | K082051 |
| 510k Number | K082051 |
| Device Name: | COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 |
| Classification | Generator, Lesion, Radiofrequency |
| Applicant | COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 -4140 |
| Contact | Louis Falcone |
| Correspondent | Louis Falcone COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 -4140 |
| Product Code | GXD |
| CFR Regulation Number | 882.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-18 |
| Decision Date | 2008-10-16 |
| Summary: | summary |