The following data is part of a premarket notification filed by North Coast Medi-tek with the FDA for Rct-1, Rct-2, Rct-3 Arthrogram Tray.
| Device ID | K870417 |
| 510k Number | K870417 |
| Device Name: | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | NORTH COAST MEDI-TEK 8603 EAST AVE. Mentor, OH 44060 |
| Contact | Theresa Sokolowski |
| Correspondent | Theresa Sokolowski NORTH COAST MEDI-TEK 8603 EAST AVE. Mentor, OH 44060 |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-03-05 |