510(k) K964614

ULTRAFERA WOUND DRESSING by American White Cross, Inc. — Product Code KMF

K964614 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "ULTRAFERA WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 6, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. American White Cross, Inc. has at least 9 other 510(k) clearances on record.