The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree, Straight View; Nephroscope, 20.
| Device ID | K994223 |
| 510k Number | K994223 |
| Device Name: | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 |
| Classification | Kit, Nephroscope |
| 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 | FGA |
| Subsequent Product Code | FEC |
| Subsequent Product Code | FED |
| Subsequent Product Code | FFL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-15 |
| Decision Date | 2000-06-05 |
| Summary: | summary |