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510(k) K093930

DIDGET WORLD REPORTS by Bayer Healthcare, LLC — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2010
Date Received
December 22, 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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