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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K935693
Device Name AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
Applicant
Vortran Medical Technology 1, Inc.
3941 J St.
Suite 354
Sacramento,  CA  95819
Applicant Contact GORDON A WONG, M.D.
Correspondent
Vortran Medical Technology 1, Inc.
3941 J St.
Suite 354
Sacramento,  CA  95819
Correspondent Contact GORDON A WONG, M.D.
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/29/1993
Decision Date 08/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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