510(k) K022159

PISTON SYRINGE & HYPODERMIC NEEDLE by International Medsurg Connection — Product Code FMF

K022159 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "PISTON SYRINGE & HYPODERMIC NEEDLE". The FDA issued a decision of Substantially Equivalent on November 7, 2002. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. International Medsurg Connection has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2002
Date Received
July 2, 2002
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