The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for 14fr Colon Decompression Set, Macon Colon Decompression Set.
| Device ID | K171619 |
| 510k Number | K171619 |
| Device Name: | 14Fr Colon Decompression Set, Macon Colon Decompression Set |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| Applicant | Cook Ireland Ltd O'Halloran Road, National Technology Park Limerick, IE |
| Contact | Laura Graham |
| Correspondent | Laura Graham Cook Ireland Ltd O'Halloran Road, National Technology Park Limerick, IE |
| Product Code | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-08-01 |
| Summary: | summary |