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510(k) K140473

DUALGUARD by Flexicare Medical, Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2014
Date Received
February 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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