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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 K041963
Device Name AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
Applicant
American Bantex Corp.
994 N. Main St.
Bountiful,  UT  84010
Applicant Contact TRACY S BEST
Correspondent
American Bantex Corp.
994 N. Main St.
Bountiful,  UT  84010
Correspondent Contact TRACY S BEST
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/21/2004
Decision Date 10/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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