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FDA 510(k), K200247, Fusion Quattro Extraction Balloon
FDA 510(k), K200247, Fusion Quattro Extraction Balloon
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510(K) Number: K200247
Device Name: Fusion Quattro Extraction Balloon
Manufacturer: Wilson-Cook Medical, Inc
Device Classification Name: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation Number: 876.5010
Classification Product Code: GCA
Date Received: 01/31/2020
Decision Date: 02/27/2020
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Fusion Quattro Extraction Balloon
Manufacturer: Wilson-Cook Medical, Inc
Device Classification Name: Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation Number: 876.5010
Classification Product Code: GCA
Date Received: 01/31/2020
Decision Date: 02/27/2020
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
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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