The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Optical Mediastinoscope With Plug-in Connection/ocular Eyepiece.
| Device ID | K971166 |
| 510k Number | K971166 |
| Device Name: | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE |
| Classification | Mediastinoscope, Surgical |
| 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 | EWY |
| CFR Regulation Number | 874.4720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-08-27 |
| Summary: | summary |