510(k) K980987

BECTON DICKINSON SYRINGE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FMF

K980987 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BECTON DICKINSON SYRINGE". The FDA issued a decision of Substantially Equivalent on June 11, 1998. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1998
Date Received
March 17, 1998
Clearance Type
Traditional
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