K852211 is an FDA 510(k) clearance for the OPSITE WOUND DRESSING. This device is classified as a Dressing, Wound, Occlusive (Class I - General Controls, product code NAD).
Submitted by Smith & Nephew, Inc. (Columbia, US). The FDA issued a Cleared decision on July 23, 1985, 63 days after receiving the submission on May 21, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K852211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | May 21, 1985 |
| Decision Date | July 23, 1985 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | NAD — Dressing, Wound, Occlusive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4020 |