The following data is part of a premarket notification filed by Canyon Medical Products with the FDA for Canyons Bi-directional Check Valve.
| Device ID | K954181 |
| 510k Number | K954181 |
| Device Name: | CANYONS BI-DIRECTIONAL CHECK VALVE |
| Classification | Dispenser, Liquid Medication |
| Applicant | CANYON MEDICAL PRODUCTS 2850 EAST 7320 SOUTH Salt Lake City, UT 84121 |
| Contact | Steven M Smith |
| Correspondent | Steven M Smith CANYON MEDICAL PRODUCTS 2850 EAST 7320 SOUTH Salt Lake City, UT 84121 |
| Product Code | KYX |
| CFR Regulation Number | 880.6430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-11-29 |