K981150 is an FDA 510(k) clearance for the SOLOSITE GEL CONFORMABLE DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on June 22, 1998, 83 days after receiving the submission on March 31, 1998.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K981150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1998 |
| Decision Date | June 22, 1998 |
| Days to Decision | 83 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 | — |