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Applied Medical Resources Corp.
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MODIFICATION TO OPTICAL SEPARATOR SYSTEM is an FDA 510(k)-cleared medical device (K041795) manufactured by Applied Medical Resources Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2004. Regulation: 8.

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