The following data is part of a premarket notification filed by Cosman Medical, Inc. with the FDA for Cosman Rf Injection Electrodes, Models Cu, Cur, Ccd, Tcd, Cp, Cr, Cn.
| Device ID | K082012 |
| 510k Number | K082012 |
| Device Name: | COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN |
| Classification | Probe, Radiofrequency Lesion |
| 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 | GXI |
| CFR Regulation Number | 882.4725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-15 |
| Decision Date | 2008-10-14 |
| Summary: | summary |