K083024 is an FDA 510(k) clearance for the HYLATOPIC EMOLLIENT FOAM. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Collegium Pharmaceutical Incorporated (Cumberland, US). The FDA issued a Cleared decision on March 27, 2009, 169 days after receiving the submission on October 9, 2008.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K083024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2008 |
| Decision Date | March 27, 2009 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |