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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 K150893
Device Name IntelliCuff
Applicant
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH 7402
Applicant Contact STEFFEN BODEN
Correspondent
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH 7402
Correspondent Contact STEFFEN BODEN
Regulation Number868.5750
Classification Product Code
BSK  
Date Received04/02/2015
Decision Date 01/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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