The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Flexible Mini-fiberscopes.
| Device ID | K962172 |
| 510k Number | K962172 |
| Device Name: | FLEXIBLE MINI-FIBERSCOPES |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Robert Casarsa |
| Correspondent | Robert Casarsa RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | FBN |
| Subsequent Product Code | FAJ |
| Subsequent Product Code | FAS |
| Subsequent Product Code | FCL |
| Subsequent Product Code | FFL |
| Subsequent Product Code | FGA |
| Subsequent Product Code | FGB |
| Subsequent Product Code | GCQ |
| Subsequent Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-05 |
| Decision Date | 1996-12-02 |
| Summary: | summary |