The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Evap-electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization Of Soft Tissue.
| Device ID | K953983 |
| 510k Number | K953983 |
| Device Name: | EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| 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 | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-23 |
| Decision Date | 1996-10-02 |
| Summary: | summary |