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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 K911759
Device Name VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
Applicant
Vortran Medical Technology 1, Inc.
3941 J St.
Suite 354
Sacramento,  CA  95819
Applicant Contact GORDON A.WONG
Correspondent
Vortran Medical Technology 1, Inc.
3941 J St.
Suite 354
Sacramento,  CA  95819
Correspondent Contact GORDON A.WONG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/18/1991
Decision Date 09/10/1991
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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