The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Morce Scope Set 8970 With Power Control 2303 And Suction Pump 2207.
| Device ID | K041610 |
| 510k Number | K041610 |
| Device Name: | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 |
| Classification | Resectoscope |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Robert L Casarsa |
| Correspondent | Robert L Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | FJL |
| Subsequent Product Code | GEY |
| Subsequent Product Code | JCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-08-19 |
| Summary: | summary |