STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)

STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES) is an FDA 510(k)-cleared medical device (K961310) 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 June 26, 1996. Regulation: 8.