The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Versastim, Perfoamax, Surgi-stim, Faststart.
| Device ID | K041953 |
| 510k Number | K041953 |
| Device Name: | VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART |
| Classification | Electrode, Cutaneous |
| Applicant | CONMED CORP. 525 FRENCH RD. Utica, NY 13502 |
| Contact | Ira Duesler |
| Correspondent | Ira Duesler CONMED CORP. 525 FRENCH RD. Utica, NY 13502 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-20 |
| Decision Date | 2004-08-09 |