
Louisville Laboratories, Inc.
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LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS is an FDA 510(k)-cleared medical device (K971796) manufactured by Louisville Laboratories, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1997. Regulation: 8.