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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K981726
Device Name PERCUSSIVETECH HF, MODEL 2001
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 Number868.5905
Classification Product Code
NHJ  
Date Received05/15/1998
Decision Date 09/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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