
Precision Endoscopy of America, Inc.
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GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS is an FDA 510(k)-cleared medical device (K970372) manufactured by Precision Endoscopy of America, 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 10, 1997. Regulation: 8.