VACUUM HANDLE MODEL I/A - 1

VACUUM HANDLE MODEL I/A - 1 is an FDA 510(k)-cleared medical device (K862343) manufactured by Cutler Medical Instruments. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 1986. Regulation: 8.