510(k) K021528

REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP by Adven Medical — Product Code JOW

K021528 is an FDA 510(k) premarket notification submitted by Adven Medical for the device "REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP". The FDA issued a decision of Substantially Equivalent on August 21, 2002. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Adven Medical has at least 5 other 510(k) clearances on record.