
Geometric Data, Div. Smithkline Corp.
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CONTEXT FILTER is an FDA 510(k)-cleared medical device (K791108) manufactured by Geometric Data, Div. Smithkline Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 1979. Regulation: 8.