K935705 is an FDA 510(k) clearance for the ALLEVYN ISLAND WOUND DRESSING. This device is classified as a Dressing, Wound, Hydrogel Without Drug And/or Biologic (Class I - General Controls, product code NAE).
Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on February 15, 1994, 77 days after receiving the submission on November 30, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4022.
| 510(k) Number | K935705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1993 |
| Decision Date | February 15, 1994 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | NAE — Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4022 |