The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Riwo Drive System 2302 With Generator, Small Motor Handles, 8563.111, 8563.351.
| Device ID | K984521 |
| 510k Number | K984521 |
| Device Name: | RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 |
| Classification | Laryngostroboscope |
| 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 | EQL |
| CFR Regulation Number | 874.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-03-17 |
| Summary: | summary |