510(k) K903159

VALVE CONTROLLER FOR MICROMACRO COMPOUNDER by Baxa Corp., Sub. of Cook Group, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1990
Date Received
July 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type