510(k) K051574

NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE by Nipro Medical Corp. — Product Code FMF

K051574 is an FDA 510(k) premarket notification submitted by Nipro Medical Corp. for the device "NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE". The FDA issued a decision of Substantially Equivalent on August 26, 2005. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Nipro Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2005
Date Received
June 14, 2005
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