K922828 is an FDA 510(k) clearance for the ULCER WOUND TRAY. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on September 28, 1992, 108 days after receiving the submission on June 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K922828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | June 12, 1992 |
| Decision Date | September 28, 1992 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |