The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Auxiliary Instruments For Urs.
| Device ID | K971315 |
| 510k Number | K971315 |
| Device Name: | AUXILIARY INSTRUMENTS FOR URS |
| Classification | Forceps, Biopsy, Non-electric |
| 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 | FCL |
| Subsequent Product Code | FAX |
| Subsequent Product Code | FFL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1997-09-15 |
| Summary: | summary |