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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K894337
Device Name UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM
Applicant
Vitaid, Ltd.
P.O. Box 123
Postal Station S., Toronto
Ontario, Canada,  CA M5M 4L6
Applicant Contact WILLIAM G STEWART
Correspondent
Vitaid, Ltd.
P.O. Box 123
Postal Station S., Toronto
Ontario, Canada,  CA M5M 4L6
Correspondent Contact WILLIAM G STEWART
Regulation Number868.5740
Classification Product Code
CBI  
Date Received07/14/1989
Decision Date 09/29/1989
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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