The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conseal Colostomy Continence System (one-piece).
| Device ID | K881636 |
| 510k Number | K881636 |
| Device Name: | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) |
| Classification | Collector, Ostomy |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-07-13 |