Home / 510(k) Clearances / K091820

510(k) K091820

CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM by Bayer Healthcare — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2009
Date Received
June 18, 2009
Clearance Type
Special
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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