K872988 is an FDA 510(k) clearance for the TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING. This device is classified as a Dressing, Wound, Occlusive (Class I - General Controls, product code NAD).
Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on September 16, 1987, 47 days after receiving the submission on July 31, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K872988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 31, 1987 |
| Decision Date | September 16, 1987 |
| Days to Decision | 47 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 |