510(k) K990955

MODIFICATION OF:BIODERM FOAM WOUND DRESSING by Bioderm, Inc. — Product Code KMF

K990955 is an FDA 510(k) premarket notification submitted by Bioderm, Inc. for the device "MODIFICATION OF:BIODERM FOAM WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on May 18, 1999. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Bioderm, Inc. has at least 10 other 510(k) clearances on record.