The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Mc 2000 Ostomy Pouches.
| Device ID | K840269 |
| 510k Number | K840269 |
| Device Name: | MC 2000 OSTOMY POUCHES |
| Classification | Collector, Ostomy |
| Applicant | COLOPLAST A/S 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-23 |
| Decision Date | 1984-04-02 |