
Vision-Sciences, Inc.
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DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE is an FDA 510(k)-cleared medical device (K963344) manufactured by Vision-Sciences, 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 November 20, 1996. Regulation: 8.