510(k) K131206
- Device
- COOK CERVICAL RIPENING BALLOON
- Applicant
- COOK, INC.
- 510(k) number
- K131206
- Product code
- PFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-09-27
- Date received
- 2013-04-29
- 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
- CHIRS KILANDER
- Address
- 750 Daniels Way Bloomington IN US 47404 47404
FDA Registration Numbers#
- 1216677
- 1718873
Source Documents#
Other 510(k) Records For Product Code PFJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143424 | UTAH CVX-RIPE | Utah Medical Products, Inc. | 2015-08-28 |
Legacy Summary#
summary
FDA Review#
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