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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K042684
Device Name WELL LEAD TRACHEOSTOMY TUBE
Applicant
Well Lead Medical Instruments
962 Allergo Ln.
Apollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
Well Lead Medical Instruments
962 Allergo Ln.
Apollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/29/2004
Decision Date 02/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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