Submission Details
| 510(k) Number | K943073 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | June 28, 1994 |
| Decision Date | July 26, 1994 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K943073 is an FDA 510(k) clearance for the CURAFIL WOUND GEL DRESSING, a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic, submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on July 26, 1994, 28 days after receiving the submission on June 28, 1994. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K943073 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | June 28, 1994 |
| Decision Date | July 26, 1994 |
| Days to Decision | 28 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 | — |