STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS

STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS is an FDA 510(k)-cleared medical device (K921460) manufactured by Storz Instrument Co.. 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 1, 1992. Regulation: 8.