The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for C-mount Objective Lens F = 17 Mm, Steam-sterilizable: Model 85 261.172, C-mount Objective Lens F = 21 Mm, Steam-steriliz.
| Device ID | K964173 |
| 510k Number | K964173 |
| Device Name: | C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| 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 | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-18 |
| Decision Date | 1996-12-13 |
| Summary: | summary |