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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K173914
Device Name VORTRAN Cuff Inflator (VCI)
Applicant
VORTRAN Medical Technology 1, Inc.
21 Goldenland Court
#100
Sacramento,  CA  95834
Applicant Contact James Lee
Correspondent
VORTRAN Medical Technology 1, Inc.
21 Goldenland Court
#100
Sacramento,  CA  95834
Correspondent Contact James Lee
Regulation Number868.5750
Classification Product Code
BSK  
Date Received12/22/2017
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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