K930401 is an FDA 510(k) clearance for the ALUMINUM FOIL. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on May 12, 1993, 106 days after receiving the submission on January 26, 1993.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K930401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1993 |
| Decision Date | May 12, 1993 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |