The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Bipolar Generator Model 2352.
| Device ID | K945914 |
| 510k Number | K945914 |
| Device Name: | BIPOLAR GENERATOR MODEL 2352 |
| 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 | 1994-12-02 |
| Decision Date | 1995-09-26 |