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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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In addition to our three core plants in Japan, Fuji Silysia Chemical also produces silica at our fully automated facility in Greenville, NC, USA and via our Sylysiamont S.p.A. operation based in Bussi, Italy. In 2012, we proudly added to our Americas footprint by expanding our Branch Office in Sao Paulo, Brazil.

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Dec 13, 2014 · The Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device.

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