K864264 is an FDA 510(k) clearance for the TRICOTEX WOUND CONTACT LAYER DRESSING. This device is classified as a Gauze / Sponge,nonresorbable For External Use (Class I - General Controls, product code NAB).
Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on December 29, 1986, 61 days after receiving the submission on October 29, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4014.
| 510(k) Number | K864264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 29, 1986 |
| Decision Date | December 29, 1986 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | NAB — Gauze / Sponge,nonresorbable For External Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4014 |