510(k) K072404

ERBE ERBEJET 2 SYSTEM by Erbe USA, Inc. — Product Code FQH

K072404 is an FDA 510(k) premarket notification submitted by Erbe USA, Inc. for the device "ERBE ERBEJET 2 SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 2007. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Erbe USA, Inc. has at least 10 other 510(k) clearances on record.