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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/bronchial, differential ventilation (w/wo connector)
510(k) Number K121462
Device Name EZ-BLOCKER
Original Applicant
EZ-BLOCKER B.V.
4655 kirkwood court
boulder,  CO  80301
Original Contact lewis ward
Regulation Number868.5740
Classification Product Code
CBI  
Date Received05/17/2012
Decision Date 09/28/2012
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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