510(k) K110656

IMC BLOOD COLLECTION NEEDLE by International Medsurg Connection — Product Code FMI

K110656 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "IMC BLOOD COLLECTION NEEDLE". The FDA issued a decision of Substantially Equivalent on August 18, 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
August 18, 2011
Date Received
March 7, 2011
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