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Stortford Medical, LLC
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RESTEP DVY SYSTEM, MODEL RSP-101 is an FDA 510(k)-cleared medical device (K090308) manufactured by Stortford Medical, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2009. Regulation: 8.