The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Cook Cervical Ripening Balloon.
| Device ID | K131206 |
| 510k Number | K131206 |
| Device Name: | COOK CERVICAL RIPENING BALLOON |
| Classification | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor |
| Applicant | COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404 |
| Contact | Chirs Kilander |
| Correspondent | Chirs Kilander COOK, INC. 750 DANIELS WAY Blmgtn, IN 47404 |
| Product Code | PFJ |
| CFR Regulation Number | 884.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2013-09-27 |
| Summary: | summary |