The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Myoma Drill 5mm-8383.611.
| Device ID | K940844 |
| 510k Number | K940844 |
| Device Name: | MYOMA DRILL 5MM-8383.611 |
| Classification | Laparoscope, Gynecologic (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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-23 |
| Decision Date | 1994-05-02 |