510(k) K080868

AONGEN COLLAGEN MATRIX by Aeon Astron Europe B.V. — Product Code KGN

K080868 is an FDA 510(k) premarket notification submitted by Aeon Astron Europe B.V. for the device "AONGEN COLLAGEN MATRIX". The FDA issued a decision of Substantially Equivalent on May 14, 2009. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Aeon Astron Europe B.V. has at least 2 other 510(k) clearances on record.