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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 (W/Wo Connector)
510(k) Number K052233
Device Name TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM
Applicant
ETVIEW LTD.
31 HAAVODA ST.
BINYAMINA,  IL
Applicant Contact YORAM LEVY
Correspondent
ETVIEW LTD.
31 HAAVODA ST.
BINYAMINA,  IL
Correspondent Contact YORAM LEVY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received08/17/2005
Decision Date 12/13/2005
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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