K061275 is an FDA 510(k) clearance for the MEDLINE SYRINGES, MULTIPLE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 19, 2006, 72 days after receiving the submission on May 8, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K061275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2006 |
| Decision Date | July 19, 2006 |
| Days to Decision | 72 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |