The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Meniscal Suture Instrumentarium.
| Device ID | K940287 |
| 510k Number | K940287 |
| Device Name: | MENISCAL SUTURE INSTRUMENTARIUM |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1994-11-22 |