AM-100 I/A AMPAC

AM-100 I/A AMPAC is an FDA 510(k)-cleared medical device (K860770) manufactured by Dravon Medical, 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 April 20, 1986. Regulation: 8.