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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 K042683
Device Name WELL LEAD ENDOTRACHEAL TUBE
Applicant
WELL LEAD MEDICAL INSTRUMENTS
962 ALLERGO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
WELL LEAD MEDICAL INSTRUMENTS
962 ALLERGO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received09/29/2004
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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