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Promedica, Inc.
Free shipping on orders over $99 · 30-day returns
THE ULTRA SYSTEM SP is an FDA 510(k)-cleared medical device (K032813) manufactured by Promedica, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 12, 2004. Regulation: 8.

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