510(k) K990438

DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING by Dermaphylyx, Inc. — Product Code MGP

K990438 is an FDA 510(k) premarket notification submitted by Dermaphylyx, Inc. for the device "DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on March 25, 1999. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Dermaphylyx, Inc. has at least 8 other 510(k) clearances on record.