The following data is part of a premarket notification filed by C & D Colostomy Pad Corp. with the FDA for Colostomy Bag.
| Device ID | K830841 |
| 510k Number | K830841 |
| Device Name: | COLOSTOMY BAG |
| Classification | Collector, Ostomy |
| Applicant | C & D COLOSTOMY PAD CORP. 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 | 1983-03-17 |
| Decision Date | 1983-07-19 |