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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K093617
Device Name VENTLAB 6000 SERIES HUMIDIFIER
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 Number868.5450
Classification Product Code
BTT  
Date Received11/23/2009
Decision Date 01/27/2011
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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