K992094 is an FDA 510(k) clearance for the GILTECH PLUS HYDROGEL SKIN DRESSING. This device is classified as a Dressing, Wound, Hydrogel Without Drug And/or Biologic (Class I - General Controls, product code NAE).
Submitted by Giltech Plus, Inc. (Milford, US). The FDA issued a Cleared decision on September 17, 1999, 88 days after receiving the submission on June 21, 1999.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4022.
| 510(k) Number | K992094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1999 |
| Decision Date | September 17, 1999 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | NAE — Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4022 |