510(k) K040649

KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE by Tyco Healthcare — Product Code JOW

K040649 is an FDA 510(k) premarket notification submitted by Tyco Healthcare for the device "KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE". The FDA issued a decision of Substantially Equivalent on July 15, 2004. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Tyco Healthcare has at least 10 other 510(k) clearances on record.