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510(k) K855000

RATEMINDER III INFUSION DEVICE by American Edwards Laboratories — Product Code LDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1986
Date Received
December 13, 1985
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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