
3Dsharp, Inc.
Free shipping on orders over $99 · 30-day returns
3DFIS, MODEL IES-FL-101 is an FDA 510(k)-cleared medical device (K013841) manufactured by 3Dsharp, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2002. Regulation: 8.