K921350 is an FDA 510(k) clearance for the QUALTEX TUBE/CORD ORGANIZER. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on August 4, 1992, 138 days after receiving the submission on March 19, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K921350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 1992 |
| Decision Date | August 04, 1992 |
| Days to Decision | 138 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 |