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510(k) K072369

EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM by Hmd Biomedical, LLC — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2008
Date Received
August 23, 2007
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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  • K120064 — TEST, BLOOD GLUCOSE SYSTEM (September 5, 2012)
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  • K032985 — GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (October 21, 2003)
  • K023279 — GLUCOLEADER VALUE (August 4, 2003)

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