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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 (W/Wo Connector)
510(k) Number K110269
Device Name WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
Applicant
WELL LEAD MEDICAL CO. LTD
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact JOHN OBRIEN
Correspondent
WELL LEAD MEDICAL CO. LTD
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact JOHN OBRIEN
Regulation Number868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSY  
Date Received01/27/2011
Decision Date 08/26/2011
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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