510(k) K102584

IMC HYPODERMIC NEEDLE by International Medsurg Connection — Product Code FMI

K102584 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "IMC HYPODERMIC NEEDLE". The FDA issued a decision of Substantially Equivalent on January 14, 2011. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. International Medsurg Connection has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2011
Date Received
September 8, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type