K112769 is an FDA 510(k) clearance for the CURAD COMPRESSION HOSIERY. This device is classified as a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II - Special Controls, product code DWL).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 1, 2012, 160 days after receiving the submission on September 23, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5780.
| 510(k) Number | K112769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2011 |
| Decision Date | March 01, 2012 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5780 |