STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)

STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION) is an FDA 510(k)-cleared medical device (K951824) manufactured by Nidek, Inc.. 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 18, 1995. Regulation: 8.