K002666 is an FDA 510(k) clearance for the DIAMOND ALOE VERA, STERILE. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.
Submitted by Medi-Tech Intl. Corp. (Brooklyn, US). The FDA issued a Cleared decision on February 27, 2001, 186 days after receiving the submission on August 25, 2000.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K002666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2000 |
| Decision Date | February 27, 2001 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Device Class | — |