K911550 is an FDA 510(k) clearance for the 2ND SKIN MOIST BURN PADS WITH ALOE. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Spenco Medical Corp. (Waco, US). The FDA issued a Cleared decision on September 6, 1991, 151 days after receiving the submission on April 8, 1991.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K911550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1991 |
| Decision Date | September 06, 1991 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |