K103736 is an FDA 510(k) clearance for the DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Dmc Medical, Ltd. (Bountiful, US). The FDA issued a Cleared decision on June 10, 2011, 170 days after receiving the submission on December 22, 2010.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K103736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2010 |
| Decision Date | June 10, 2011 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |