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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 K092886
Device Name WELL LEAD ENDOBRONCHIAL TUBES
Applicant
Well Lead Instruments
962 Allegro Lane
Apollo Beach,  FL  33570
Applicant Contact ARTHUR WARD
Correspondent
Well Lead Instruments
962 Allegro Lane
Apollo Beach,  FL  33570
Correspondent Contact ARTHUR WARD
Regulation Number868.5740
Classification Product Code
CBI  
Date Received09/21/2009
Decision Date 03/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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