510(k) K171362

Merit Syringe by Merit Medical Systems, Inc. — Product Code FMF

K171362 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Merit Syringe". The FDA issued a decision of Substantially Equivalent on Aug 7, 2017. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 7, 2017
Date Received
May 9, 2017
Clearance Type
Abbreviated
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)