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Endooptiks, Inc.
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ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR is an FDA 510(k)-cleared medical device (K083788) manufactured by Endooptiks, Inc.. 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 March 2, 2009. Regulation: 8.

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