K981713 is an FDA 510(k) clearance for the CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on July 31, 1998, 77 days after receiving the submission on May 15, 1998.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K981713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 1998 |
| Decision Date | July 31, 1998 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |