FDA 510(k), K960415, WILSON-COOK BALLOON INFLATION DEVICE

FDA 510(k), K960415, WILSON-COOK BALLOON INFLATION DEVICE

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510(K) Number: K960415
Device Name: WILSON-COOK BALLOON INFLATION DEVICE
Manufacturer: WILSON-COOK MEDICAL, INC.
Device Classification Name: tubes, gastrointestinal (and accessories)
Regulation Number: 876.5980
Classification Product Code: KNT
Date Received: 01/29/1996
Decision Date: 04/26/1996
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

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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