The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Panoview Plus Optic With 2.7mm Diameter, Model 8672.xxx, Panoview Plus Optic With 1.9mm Diameter, Model 8686.xxx.
| Device ID | K984607 |
| 510k Number | K984607 |
| Device Name: | PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX |
| Classification | Telescope, Rigid, Endoscopic |
| 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 | FBP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-28 |
| Decision Date | 1999-03-05 |
| Summary: | summary |