K992005 is an FDA 510(k) clearance for the GILTECH PLUS TRANSPARENT DRESSING. This device is classified as a Dressing, Wound And Burn, Occlusive.
Submitted by Giltech Plus, Inc. (Milford, US). The FDA issued a Cleared decision on September 3, 1999, 80 days after receiving the submission on June 15, 1999.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K992005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1999 |
| Decision Date | September 03, 1999 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MGP — Dressing, Wound And Burn, Occlusive |
| Device Class | — |