K023419 is an FDA 510(k) clearance for the TRILAMINATE DRAPES/TIBURON. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on February 11, 2003, 123 days after receiving the submission on October 11, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K023419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2002 |
| Decision Date | February 11, 2003 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |