The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Resection Pump, Resectoscope For Chip Aspiration, Endoscope 25/ 3.3 Mm, Accessories.
| Device ID | K042523 |
| 510k Number | K042523 |
| Device Name: | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES |
| Classification | Resectoscope |
| 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 | FJL |
| Subsequent Product Code | HIH |
| Subsequent Product Code | KQT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-17 |
| Decision Date | 2005-03-18 |
| Summary: | summary |