K832908 is an FDA 510(k) clearance for the COMFEEL PROTECTIVE RINGS. This device is classified as a Protector, Wound, Plastic (Class I - General Controls, product code EYF).
Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983, 105 days after receiving the submission on August 29, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4014.
| 510(k) Number | K832908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1983 |
| Decision Date | December 12, 1983 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EYF — Protector, Wound, Plastic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4014 |