STORZ PREMIERE(R) MICROSURGICAL SYSTEM

STORZ PREMIERE(R) MICROSURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K946227) 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 March 21, 1995. Regulation: 8.