FDA 510(k), K092221, COLONIC SPLINTING OVERTUBE, MODEL 00711145

FDA 510(k), K092221, COLONIC SPLINTING OVERTUBE, MODEL 00711145

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510(K) Number: K092221
Device Name: COLONIC SPLINTING OVERTUBE, MODEL 00711145
Manufacturer: UNITED STATES ENDOSCOPY GROUP, INC.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 07/22/2009
Decision Date: 10/20/2009
Regulation Medical Specialty: Gastroenterology/Urology

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