The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for S-line Bipolar Resectoscopes And Bipolar Electrodes.
| Device ID | K062720 |
| 510k Number | K062720 |
| Device Name: | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES |
| 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 | FAS |
| Subsequent Product Code | FDC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-12 |
| Decision Date | 2007-03-22 |
| Summary: | summary |