The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corp. with the FDA for Multifuction Suction Irrigation System, Existing Of Suction Irrigation Handles, Suction Irrigation Tubes, And Tube Sets;.
| Device ID | K002000 |
| 510k Number | K002000 |
| Device Name: | MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS; |
| 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 | 2000-06-30 |
| Decision Date | 2001-04-10 |