510(k) K113241

BD EMERALD SINGLE USE, HYPODERMIC SYRINGE by Becton Dickinson — Product Code FMF

K113241 is an FDA 510(k) premarket notification submitted by Becton Dickinson for the device "BD EMERALD SINGLE USE, HYPODERMIC SYRINGE". The FDA issued a decision of Substantially Equivalent on November 28, 2011. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Becton Dickinson has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2011
Date Received
November 2, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type