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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K873477
Device Name INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)
Applicant
Vortran Medical Technology 1, Inc.
1600 Sacramento Inn Way
Suite 132
Sacramento,  CA  95815
Applicant Contact WONG, M.D.
Correspondent
Vortran Medical Technology 1, Inc.
1600 Sacramento Inn Way
Suite 132
Sacramento,  CA  95815
Correspondent Contact WONG, M.D.
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received08/31/1987
Decision Date 10/09/1987
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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