The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Flexible Fiberscope, Model 7331.001, Guide Section For Lithovac Handpiece, Model 8708.253.
| Device ID | K991178 |
| 510k Number | K991178 |
| Device Name: | FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Rpbert L Casarsa |
| Correspondent | Rpbert 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 | 1999-04-07 |
| Decision Date | 1999-06-11 |
| Summary: | summary |