
Surgin, Inc.
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PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI is an FDA 510(k)-cleared medical device (K013337) manufactured by Surgin, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 12, 2001. Regulation: 8.