The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Conseal(tm) Colostomy Continence System.
| Device ID | K863830 |
| 510k Number | K863830 |
| Device Name: | CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM |
| Classification | Pouch, Colostomy |
| 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 | EZQ |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-10-16 |