WALLACH LEAP 100 ELECTRO SURGERY SYSTEM

WALLACH LEAP 100 ELECTRO SURGERY SYSTEM is an FDA 510(k)-cleared medical device (K921791) manufactured by Wallach Surgical Devices, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1995. Regulation: 8.