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Isoray Medical, Inc.
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PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 is an FDA 510(k)-cleared medical device (K092136) manufactured by Isoray Medical, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2009. Regulation: 8.