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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 K010596
Device Name RUSCH BRONCHUS BLOCKER KIT
Applicant
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number868.5740
Classification Product Code
CBI  
Date Received02/28/2001
Decision Date 11/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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