510(k) K980580

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

K980580 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BECTON DICKINSON SYRINGES". The FDA issued a decision of Substantially Equivalent on June 25, 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 25, 1998
Date Received
February 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