Submission Details
| 510(k) Number | K113241 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 02, 2011 |
| Decision Date | November 28, 2011 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
Nov 2011
Decision
26d
Days
Class 2
Risk
About This 510(k) Submission
K113241 is an FDA 510(k) clearance for the BD EMERALD SINGLE USE, HYPODERMIC SYRINGE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on November 28, 2011, 26 days after receiving the submission on November 2, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.
Device Classification
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5860 |
Manufacturer
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