K962205 is an FDA 510(k) clearance for the STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 26, 1996, 172 days after receiving the submission on June 7, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K962205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1996 |
| Decision Date | November 26, 1996 |
| Days to Decision | 172 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 |