K060046 is an FDA 510(k) clearance for the DERMASTREAM. This device is classified as a Dressing, Wound, Occlusive (Class I - General Controls, product code NAD).
Submitted by Enzysurge , Ltd. (Somerset, US). The FDA issued a Cleared decision on February 27, 2006, 52 days after receiving the submission on January 6, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K060046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2006 |
| Decision Date | February 27, 2006 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAD - Dressing, Wound, Occlusive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4020 |