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Gish Biomedical, Inc.
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GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING is an FDA 510(k)-cleared medical device (K030726) manufactured by Gish Biomedical, Inc.. 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 29, 2003. Regulation: 8.