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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 DRIVE
MOCKSVILLE,  NC  27028
Applicant Contact JAMES A COCHIE
Correspondent
VENTLAB CORP.
155 BOYCE DRIVE
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
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