The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Coloplast Convex Ring.
| Device ID | K861070 |
| 510k Number | K861070 |
| Device Name: | COLOPLAST CONVEX RING |
| Classification | Collector, Ostomy |
| Applicant | COLOPLAST A/S C/O RICHARD HAMER ASSOC., INC. P.O. BOX 16598 Ft. Worth, TX 76162 |
| Contact | & Assoc |
| Correspondent | & Assoc 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 | 1986-03-20 |
| Decision Date | 1986-06-16 |