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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 K121028
Device Name ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))
Original Applicant
ETVIEW LTD.
31 haavoda st.
binyamina,  IL 30500
Original Contact yoram levy
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/05/2012
Decision Date 06/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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