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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K122721
Device Name AG GUFFILL
Original Applicant
HOSPITECH RESPIRATION LTD.
31 haavoda st
binyamina,  IS 30500
Original Contact yoram levy
Regulation Number868.5750
Classification Product Code
BSK  
Date Received09/05/2012
Decision Date 05/03/2013
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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