K834343 is an FDA 510(k) clearance for the COMFEEL POWDER. This device is classified as a Beads, Hydrophilic, For Wound Exudate Absorption (Class I - General Controls, product code KOZ).
Submitted by Coloplast A/S (Walker, US). The FDA issued a Cleared decision on November 8, 1984, 332 days after receiving the submission on December 12, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4018.
| 510(k) Number | K834343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1983 |
| Decision Date | November 08, 1984 |
| Days to Decision | 332 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KOZ — Beads, Hydrophilic, For Wound Exudate Absorption |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4018 |