The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Cosman Coagulator (cc-1) System.
| Device ID | K973297 |
| 510k Number | K973297 |
| Device Name: | COSMAN COAGULATOR (CC-1) SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Contact | William Rittman |
| Correspondent | William Rittman RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524002781 | K973297 | 000 |
| 10884524002088 | K973297 | 000 |
| 40884524000931 | K973297 | 000 |
| 20884524000944 | K973297 | 000 |
| 20884524001149 | K973297 | 000 |
| 20884524001156 | K973297 | 000 |
| 20884524001170 | K973297 | 000 |
| 20884524001187 | K973297 | 000 |
| 20884524001194 | K973297 | 000 |
| 20884524001200 | K973297 | 000 |
| 20884524001217 | K973297 | 000 |
| 20884524001224 | K973297 | 000 |
| 20884524001231 | K973297 | 000 |
| 20884524001286 | K973297 | 000 |
| 10884524001548 | K973297 | 000 |
| 10884524002774 | K973297 | 000 |
| 10884521133198 | K973297 | 000 |
| 10884521133181 | K973297 | 000 |