510(k) K842415

ALL-HANDS TRACHEOSTOMY CARE SET 0101 by All-Hands Medical Supply, Inc. — Product Code BTO

K842415 is an FDA 510(k) premarket notification submitted by All-Hands Medical Supply, Inc. for the device "ALL-HANDS TRACHEOSTOMY CARE SET 0101". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. All-Hands Medical Supply, Inc. has at least 2 other 510(k) clearances on record.