The following data is part of a premarket notification filed by Cosman Medical, Inc. with the FDA for Cosman Rf Lesion Generator, Model Rfg-1a; Cosman Tew Trigeminal Electrode Kit; Cosman Tic Trigeminal Electrode Kit;.
| Device ID | K050084 |
| 510k Number | K050084 |
| Device Name: | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; |
| Classification | Probe, Radiofrequency Lesion |
| Applicant | COSMAN MEDICAL, INC. 76 CAMBRIDGE ST. Burlington, MA 01803 -4140 |
| Contact | Michael Arnold |
| Correspondent | Michael Arnold 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 | 2005-01-13 |
| Decision Date | 2005-03-17 |
| Summary: | summary |