The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Disposable Manifold.
| Device ID | K854960 |
| 510k Number | K854960 |
| Device Name: | DISPOSABLE MANIFOLD |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Gordon Bartlett |
| Correspondent | Gordon Bartlett UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-11 |
| Decision Date | 1986-02-10 |