The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Riwo System Trays.
| Device ID | K012309 |
| 510k Number | K012309 |
| Device Name: | RIWO SYSTEM TRAYS |
| Classification | Accessories, Cleaning, For Endoscope |
| 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 | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-10-19 |
| Summary: | summary |