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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dropper, Ether
510(k) Number K093126
Device Name ANAPNOGUARD ENDOTRACHEAL TUBE
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 Number868.5420
Classification Product Code
BTP  
Date Received10/02/2009
Decision Date 03/02/2010
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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