The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Fluted Suction Meniscal Cutter.
| Device ID | K850789 |
| 510k Number | K850789 |
| Device Name: | FLUTED SUCTION MENISCAL CUTTER |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | T. KOROS SURGICAL INSTRUMENTS CORP. 2524 TOWNSGATE RD. UNIT D Westlake, CA 91361 |
| Contact | Tibor B Koros |
| Correspondent | Tibor B Koros T. KOROS SURGICAL INSTRUMENTS CORP. 2524 TOWNSGATE RD. UNIT D Westlake, CA 91361 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-06-28 |