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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 K943600
Device Name UNIHEART
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J ST., SUITE 354
SACRAMENTO,  CA  95819
Applicant Contact GORSON A WONG
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J ST., SUITE 354
SACRAMENTO,  CA  95819
Correspondent Contact GORSON A WONG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/25/1994
Decision Date 10/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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