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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K063813
Device Name VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
Applicant
Ventlab Corp.
155 Boyce Dr.
Mocksville,  NC  27028
Applicant Contact JAMES A COCHIE
Correspondent
Ventlab Corp.
155 Boyce Dr.
Mocksville,  NC  27028
Correspondent Contact JAMES A COCHIE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/22/2006
Decision Date 03/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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