
Westmark, Sterile Packing Systems, Inc. (Sps)
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CYSTO PUMP DRAINAGE BAG is an FDA 510(k)-cleared medical device (K896208) manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 17, 1990. Regulation: 8.