510(k) K143424
- Device
- UTAH CVX-RIPE
- Applicant
- UTAH MEDICAL PRODUCTS, INC.
- 510(k) number
- K143424
- Product code
- PFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-28
- Date received
- 2014-12-01
- Regulation
- 884.4260
- Classification name
- Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ben Shirley
- Address
- 7043 S. 300 W. Midvale UT US 84047 84047
FDA Registration Numbers#
- 1216677
- 1718873
Source Documents#
Other 510(k) Records For Product Code PFJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131206 | COOK CERVICAL RIPENING BALLOON | Cook, Inc. | 2013-09-27 |
Legacy Summary#
summary
FDA Review#
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