The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes.
| Device ID | K980302 |
| 510k Number | K980302 |
| Device Name: | WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| Subsequent Product Code | FAS |
| Subsequent Product Code | FDC |
| Subsequent Product Code | FJL |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-27 |
| Decision Date | 1998-07-20 |
| Summary: | summary |