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Pari Holding Co.
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PRONEB ULTRA MODEL NUMBER 85B0100 is an FDA 510(k)-cleared medical device (K002862) manufactured by Pari Holding Co.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2001. Regulation: 8.