The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Coloplast-duraseal Ostomy Appliance.
| Device ID | K780409 |
| 510k Number | K780409 |
| Device Name: | COLOPLAST-DURASEAL OSTOMY APPLIANCE |
| Classification | Appliance, Colostomy, Disposable |
| Applicant | C.R. BARD, INC. 110 MARSHALL DRIVE Warrandale, PA 15086 |
| Product Code | EZS |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-13 |
| Decision Date | 1978-04-27 |