
Premco Medical Systems, Inc.
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PRODIGY NPWT SYSTEM MODEL PRODIGY 800V is an FDA 510(k)-cleared medical device (K082415) manufactured by Premco Medical Systems, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 24, 2008. Regulation: 8.