The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Hysteroscope Operating Sheath And Insert, Model 8988.031/.041/.231/.241.
| Device ID | K000673 |
| 510k Number | K000673 |
| Device Name: | HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-05-26 |