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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 K040507
Device Name TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
Applicant
TAGA MEDICAL TECHNOLOGIES, INC.
34675 VOKES DR.
SUITE 105
EASTLAKE,  OH  44095
Applicant Contact GARY AUSTIN
Correspondent
TAGA MEDICAL TECHNOLOGIES, INC.
34675 VOKES DR.
SUITE 105
EASTLAKE,  OH  44095
Correspondent Contact GARY AUSTIN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/27/2004
Decision Date 03/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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