The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Power Control 2303 With Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851.
| Device ID | K030082 |
| 510k Number | K030082 |
| Device Name: | POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 |
| 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 |
| 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 | 2003-01-09 |
| Decision Date | 2003-10-30 |
| Summary: | summary |