510(k) K971801

LAPAROTOMY BLADDER NECK SUSPENSION KIT by Louisville Laboratories, Inc. — Product Code EZL

K971801 is an FDA 510(k) premarket notification submitted by Louisville Laboratories, Inc. for the device "LAPAROTOMY BLADDER NECK SUSPENSION KIT". The FDA issued a decision of Substantially Equivalent on July 22, 1997. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Louisville Laboratories, Inc. has at least 10 other 510(k) clearances on record.