The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for 12 Ureteroscopes/uretero-renoscopes.
| Device ID | K963855 |
| 510k Number | K963855 |
| Device Name: | 12 URETEROSCOPES/URETERO-RENOSCOPES |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| 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 | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-04-03 |
| Summary: | summary |