The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Urethrotome 8667.xxx And 8670.xxx.
| Device ID | K000905 |
| 510k Number | K000905 |
| Device Name: | URETHROTOME 8667.XXX AND 8670.XXX |
| Classification | Urethrotome |
| 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 | EZO |
| CFR Regulation Number | 876.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-21 |
| Decision Date | 2000-05-12 |