The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Shelf Life Change Of Sterile Devices.
| Device ID | K864090 |
| 510k Number | K864090 |
| Device Name: | SHELF LIFE CHANGE OF STERILE DEVICES |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Edwin O Goodman |
| Correspondent | Edwin O Goodman UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1987-03-20 |