510(k) K101721

WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA by Regulatory and Marketing Services, Inc. — Product Code BTO

K101721 is an FDA 510(k) premarket notification submitted by Regulatory and Marketing Services, Inc. for the device "WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA". The FDA issued a decision of Substantially Equivalent on March 24, 2011. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Regulatory and Marketing Services, Inc. has at least 10 other 510(k) clearances on record.