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Philips Medical Systems North America Co.
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PHILIPS FRESCO RELEASE 1 is an FDA 510(k)-cleared medical device (K031836) manufactured by Philips Medical Systems North America Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 2003. Regulation: 8.