510(k) K131206 ยท PFJ Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
COOK CERVICAL RIPENING BALLOON
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Sep 27, 2013 |
| Received | Apr 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131206
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.