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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 K120334
Device Name VIVA EB
Original Applicant
31 haavoda st.
binyamina,  IL 30500
Original Contact yoram levy
Regulation Number868.5740
Classification Product Code
Date Received02/03/2012
Decision Date 06/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No