510(k) K943733

FLEXIFLO SIX ENTERAL NUTRITION PUMP by Abbott Mfg., Inc. — Product Code LZH

K943733 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "FLEXIFLO SIX ENTERAL NUTRITION PUMP". The FDA issued a decision of ST on December 12, 1994. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
December 12, 1994
Date Received
August 2, 1994
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