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FDA 510(k), K171810, Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
FDA 510(k), K171810, Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
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510(K) Number: K171810
Device Name: Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Manufacturer: Cook Incorporated
Device Classification Name: catheter, urological
Regulation Number: 876.5130
Classification Product Code: KOD
Date Received: 06/19/2017
Decision Date: 03/07/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Manufacturer: Cook Incorporated
Device Classification Name: catheter, urological
Regulation Number: 876.5130
Classification Product Code: KOD
Date Received: 06/19/2017
Decision Date: 03/07/2018
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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