The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Riwo Cut-morcellator Existing Of Knife/cutting Sleeve/protection Sleeve/claw Grasping Forceps.
| Device ID | K970105 |
| 510k Number | K970105 |
| Device Name: | RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS |
| Classification | Laparoscope, Gynecologic (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 | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-13 |
| Decision Date | 1997-03-04 |
| Summary: | summary |