The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Ostomy Irrigation Set.
| Device ID | K121833 |
| 510k Number | K121833 |
| Device Name: | OSTOMY IRRIGATION SET |
| Classification | Irrigator, Ostomy |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Contact | Tim Crabtree |
| Correspondent | Tim Crabtree COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Product Code | EXD |
| CFR Regulation Number | 876.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-22 |
| Decision Date | 2012-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932027953 | K121833 | 000 |