510(k) K102969

IMC PISTON SYRINGES by International Medsurg Connection — Product Code FMF

K102969 is an FDA 510(k) premarket notification submitted by International Medsurg Connection for the device "IMC PISTON SYRINGES". The FDA issued a decision of Substantially Equivalent on December 20, 2010. 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
December 20, 2010
Date Received
October 6, 2010
Clearance Type
Special
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