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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 K010578
Device Name TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017
Applicant
TAGA MEDICAL TECHNOLOGIES, INC.
7561 TYLER BLVD.
UNIT 8
MENTOR,  OH  44060
Applicant Contact GARY AUSTIN
Correspondent
TAGA MEDICAL TECHNOLOGIES, INC.
7561 TYLER BLVD.
UNIT 8
MENTOR,  OH  44060
Correspondent Contact GARY AUSTIN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/27/2001
Decision Date 04/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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