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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
Applicant
HOSPITECH RESPIRATION LTD.
31 HAAVODA ST
BINYAMINA,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
HOSPITECH RESPIRATION LTD.
31 HAAVODA ST
BINYAMINA,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number868.5750
Classification Product Code
BSK  
Date Received09/05/2012
Decision Date 05/03/2013
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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