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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 K101721
Device Name WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Applicant
REGULATORY AND MARKETING SERVICES, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
REGULATORY AND MARKETING SERVICES, INC.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/18/2010
Decision Date 03/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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