The following data is part of a premarket notification filed by Rf Surgical Systems, Inc. with the FDA for Rf Surgical Systems Inc. Detection System, Model 100a.
| Device ID | K062642 |
| 510k Number | K062642 |
| Device Name: | RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A |
| Classification | Counter, Sponge, Surgical |
| Applicant | RF SURGICAL SYSTEMS, INC. 2700 RICHARDS ROAD SUITE 204 Bellevue, WA 98005 |
| Contact | Kevin Cosens |
| Correspondent | Kevin Cosens RF SURGICAL SYSTEMS, INC. 2700 RICHARDS ROAD SUITE 204 Bellevue, WA 98005 |
| Product Code | LWH |
| CFR Regulation Number | 880.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-06 |
| Decision Date | 2006-11-02 |
| Summary: | summary |