PRIZM KERATOME BLADE, MODEL MK8512M2

PRIZM KERATOME BLADE, MODEL MK8512M2 is an FDA 510(k)-cleared medical device (K033236) 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 March 25, 2004. Regulation: 8.