
Graham Medical Products
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DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 is an FDA 510(k)-cleared medical device (K913447) manufactured by Graham Medical Products. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1992. Regulation: 8.