The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Bipolar Forceps, Kleppinger Insert, Model #'s 8393.741,8393.771,8394.741,8394.771.
| Device ID | K990147 |
| 510k Number | K990147 |
| Device Name: | BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (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 | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-04-16 |
| Summary: | summary |