510(k) K132553

U&U STERILE PISTON SYRINGE WITHOUT NEEDLE by U&U Medical Technology Co, Ltd. — Product Code FMF

K132553 is an FDA 510(k) premarket notification submitted by U&U Medical Technology Co, Ltd. for the device "U&U STERILE PISTON SYRINGE WITHOUT NEEDLE". The FDA issued a decision of Substantially Equivalent on Feb 27, 2014. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. U&U Medical Technology Co, Ltd. has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 27, 2014
Date Received
Aug 14, 2013
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
510(k)