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510(k) K111268

CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM by Bayer Healthcare — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2012
Date Received
May 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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