The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Bipolar Forceps.
Device ID | K023813 |
510k Number | K023813 |
Device Name: | BIPOLAR FORCEPS |
Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-15 |
Decision Date | 2003-01-17 |
Summary: | summary |