510(k) K915572

BECTON DICKINSON MODIFIED MENGHINI NEEDLE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GDM

K915572 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BECTON DICKINSON MODIFIED MENGHINI NEEDLE". The FDA issued a decision of Substantially Equivalent on February 3, 1992. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1992
Date Received
December 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type