510(k) K030574

GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER by Glustitch, Inc. — Product Code KMF

K030574 is an FDA 510(k) premarket notification submitted by Glustitch, Inc. for the device "GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER". The FDA issued a decision of Substantially Equivalent on August 21, 2003. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Glustitch, Inc. has at least 4 other 510(k) clearances on record.