K840362 is an FDA 510(k) clearance for the COMFEEL PASTE..
Submitted by Coloplast A/S (Fort Worth, US). The FDA issued a Cleared decision on November 7, 1984, 286 days after receiving the submission on January 26, 1984.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K840362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1984 |
| Decision Date | November 07, 1984 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | — |
| Device Class | — |