The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Comfeel Protective Rings.
| Device ID | K832908 |
| 510k Number | K832908 |
| Device Name: | COMFEEL PROTECTIVE RINGS |
| Classification | Protector, Wound, Plastic |
| Applicant | COLOPLAST A/S 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EYF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-29 |
| Decision Date | 1983-12-12 |