K820134 is an FDA 510(k) clearance for the VIGILON PRIMARY WOUND DRESSING, STERILE. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982, 18 days after receiving the submission on January 18, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K820134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 1982 |
| Decision Date | February 05, 1982 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |