510(k) K182589

BD Plastipak Syringe by Becton, Dickinson And Company — Product Code FMF

K182589 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Plastipak Syringe". The FDA issued a decision of Substantially Equivalent on Mar 14, 2019. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Becton, Dickinson And Company has 329 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 14, 2019
Date Received
Sep 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type
510(k)