The following data is part of a premarket notification filed by Terray Manufacturing, Inc. with the FDA for Casf Sterilization Tray.
| Device ID | K883125 |
| 510k Number | K883125 |
| Device Name: | CASF STERILIZATION TRAY |
| Classification | Tray, Surgical, Instrument |
| Applicant | TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
| Contact | Judy Wilson |
| Correspondent | Judy Wilson TERRAY MANUFACTURING, INC. 24 MCGONIGAL ST. WEST ARNPRIOR Ontario K7s 1l8, CA |
| Product Code | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-08-10 |