K941545 is an FDA 510(k) clearance for the ADVANTAGE SYRINGE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 23, 1994, 54 days after receiving the submission on March 30, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K941545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 1994 |
| Decision Date | May 23, 1994 |
| Days to Decision | 54 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 |