The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Utah Cvx-ripe.
| Device ID | K143424 |
| 510k Number | K143424 |
| Device Name: | UTAH CVX-RIPE |
| Classification | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Contact | Ben Shirley |
| Correspondent | Ben Shirley UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
| Product Code | PFJ |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-01 |
| Decision Date | 2015-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671CVX1001 | K143424 | 000 |