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510(k) K062058

ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 by Bayer Healthcare — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2006
Date Received
July 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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