510(k) K111381

MEDI-SIS SYRINGE INFUSION SYSTEM by Acacia, Inc. — Product Code LZH

K111381 is an FDA 510(k) premarket notification submitted by Acacia, Inc. for the device "MEDI-SIS SYRINGE INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 13, 2012. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Acacia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2012
Date Received
May 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Enteral
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type