510(k) K922760

ATRAUM WOUND DRESSING--MODIFICATION by Axiom Medical, Inc. — Product Code KMF

K922760 is an FDA 510(k) premarket notification submitted by Axiom Medical, Inc. for the device "ATRAUM WOUND DRESSING--MODIFICATION". The FDA issued a decision of Substantially Equivalent on October 30, 1992. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Axiom Medical, Inc. has at least 10 other 510(k) clearances on record.