The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Endoscope Set For Magnetic Resonance (mr), Models 8767.412, 8767.121 & 8767.452.
| Device ID | K022198 |
| 510k Number | K022198 |
| Device Name: | ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 |
| Classification | Endoscope, Neurological |
| 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 | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2003-03-21 |
| Summary: | summary |