510(k) K990761

TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE by Tuttnauer U.S.A Co, Ltd. — Product Code FRG

K990761 is an FDA 510(k) premarket notification submitted by Tuttnauer U.S.A Co, Ltd. for the device "TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE". The FDA issued a decision of Substantially Equivalent on July 9, 1999. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Tuttnauer U.S.A Co, Ltd. has at least 8 other 510(k) clearances on record.