The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Irrigation/suction Handle And Sheath.
| Device ID | K963757 |
| 510k Number | K963757 |
| Device Name: | IRRIGATION/SUCTION HANDLE AND SHEATH |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-18 |
| Decision Date | 1996-11-26 |
| Summary: | summary |