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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 K073383
Device Name WELL LEAD REINFORCED ENDOTRACHEAL TUBE
Applicant
Well Lead Medical Instruments
962 Allergo Lane
Apollo Beach,  FL  33572
Applicant Contact ARTHUR J WARD
Correspondent
Well Lead Medical Instruments
962 Allergo Lane
Apollo Beach,  FL  33572
Correspondent Contact ARTHUR J WARD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/03/2007
Decision Date 07/10/2008
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
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