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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 K082420
Device Name TRACHEOSCOPIC VENTILATION TUBE (TVT)
Applicant
ETVIEW
31 HAAVODA ST
BINYAMINA,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
ETVIEW
31 HAAVODA ST
BINYAMINA,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received08/22/2008
Decision Date 10/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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