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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))
Applicant
ETVIEW LTD.
31 haavoda st.
binyamina, 
Contact yoram levy
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/05/2012
Decision Date 06/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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