510(k) K971802

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION by Louisville Laboratories, Inc. — Product Code MBI

K971802 is an FDA 510(k) premarket notification submitted by Louisville Laboratories, Inc. for the device "VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION". The FDA issued a decision of Substantially Equivalent on July 30, 1997. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Louisville Laboratories, Inc. has at least 10 other 510(k) clearances on record.