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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 K963910
Device Name HEART NEBULIZER #100609
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 Received09/30/1996
Decision Date 12/16/1996
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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