The following data is part of a premarket notification filed by T. Koros Surgical Instruments Corp. with the FDA for Arthroscopy Suction Biopsy Punch.
| Device ID | K850527 |
| 510k Number | K850527 |
| Device Name: | ARTHROSCOPY SUCTION BIOPSY PUNCH |
| Classification | Instrument, Cutting, Orthopedic |
| Applicant | T. KOROS SURGICAL INSTRUMENTS CORP. 2524 TOWNSGATE RD. UNIT D Westlake, CA 91361 |
| Contact | Koros |
| Correspondent | Koros T. KOROS SURGICAL INSTRUMENTS CORP. 2524 TOWNSGATE RD. UNIT D Westlake, CA 91361 |
| Product Code | HTZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-07 |
| Decision Date | 1985-03-14 |