510(k) K171619 ยท FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
14Fr Colon Decompression Set, Macon Colon Decompression Set
| Applicant | Cook Ireland, Ltd., Limerick, IE |
| Decision | Substantially Equivalent, Aug 1, 2017 |
| Received | Jun 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171619
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.