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510(k) K894111

VARI-SET by Sonex Medical — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
June 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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