510(k) K112191

HEALEX BIOSPONGE WOUND DRESSING by Bionova Medical, Inc. — Product Code KGN

K112191 is an FDA 510(k) premarket notification submitted by Bionova Medical, Inc. for the device "HEALEX BIOSPONGE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on June 5, 2012. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Bionova Medical, Inc. has at least 5 other 510(k) clearances on record.