The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Unipolar Hook Electrode (5mm .340mm)/unipolar Hook Electrode (5mm. 420mm).
| Device ID | K964329 |
| 510k Number | K964329 |
| Device Name: | UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-30 |
| Decision Date | 1997-05-21 |
| Summary: | summary |