K850282 is an FDA 510(k) clearance for the HYPAFIX POST OPERATIVE 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 May 7, 1985, 104 days after receiving the submission on January 23, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K850282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1985 |
| Decision Date | May 07, 1985 |
| Days to Decision | 104 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 |