The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Power Drive Art1 2304 With Motor Handles, Tools And Accessories.
| Device ID | K080617 |
| 510k Number | K080617 |
| Device Name: | POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES |
| Classification | Arthroscope |
| Applicant | RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Contact | Niels Schmidt |
| Correspondent | Niels Schmidt RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 CORPORATE WOODS PKWY. Vernon Hills, IL 60061 |
| Product Code | HRX |
| Subsequent Product Code | ERL |
| Subsequent Product Code | GEY |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-04 |
| Decision Date | 2008-06-27 |
| Summary: | summary |