510(k) K110901

SYMBIQ INFUSION AND ADMINSTRATION SET by Hospira, Inc. — Product Code FRN

K110901 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "SYMBIQ INFUSION AND ADMINSTRATION SET". The FDA issued a decision of Substantially Equivalent on March 5, 2012. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Hospira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2012
Date Received
March 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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