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International Business Strategies
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SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES is an FDA 510(k)-cleared medical device (K062149) manufactured by International Business Strategies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 30, 2007. Regulation: 8.