FDA 510(k), K100081, ENTEROSCOPY OVERTUBE, MODEL 00712140

FDA 510(k), K100081, ENTEROSCOPY OVERTUBE, MODEL 00712140

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510(K) Number: K100081
Device Name: ENTEROSCOPY OVERTUBE, MODEL 00712140
Manufacturer: BOB BISHUI
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: FED
Classification Product Code: KXA
Date Received: 01/12/2010
Decision Date: 04/12/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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