PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD

PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD is an FDA 510(k)-cleared medical device (K033182) manufactured by Surgin Surgical Instrumentation, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 29, 2004. Regulation: 8.