K032065 is an FDA 510(k) clearance for the MEDLINE BAND BAGS AND EQUIPMENT COVERS. This device is classified as a Cover, Barrier, Protective (Class II - Special Controls, product code MMP).
Submitted by Medline Industries, Inc. (Waukegan, US). The FDA issued a Cleared decision on September 22, 2003, 81 days after receiving the submission on July 3, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K032065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2003 |
| Decision Date | September 22, 2003 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | MMP — Cover, Barrier, Protective |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |