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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 K021920
Device Name 7.0 FR. ENDOBRONCHIAL BLOCKER
Applicant
Cook, Inc.
P.O Box 489
Bloomington,  IN  47402 -0489
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
P.O Box 489
Bloomington,  IN  47402 -0489
Correspondent Contact APRIL LAVENDER
Regulation Number868.5740
Classification Product Code
CBI  
Subsequent Product Code
BTS  
Date Received06/11/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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