K874554 is an FDA 510(k) clearance for the ENVICLUSIVE (TM). This device is classified as a Dressing, Wound, Occlusive (Class I - General Controls, product code NAD).
Submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on March 11, 1988, 128 days after receiving the submission on November 4, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K874554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1987 |
| Decision Date | March 11, 1988 |
| Days to Decision | 128 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 |