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FDA 510(k), K150891, BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
FDA 510(k), K150891, BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
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510(K) Number: K150891
Device Name: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
Manufacturer: Covidien LLC( Formerly Beacon Endoscopic Corp.)
Device Classification Name: biopsy needle
Regulation Number: 876.1075
Classification Product Code: FCG
Date Received: 04/02/2015
Decision Date: 05/01/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
Manufacturer: Covidien LLC( Formerly Beacon Endoscopic Corp.)
Device Classification Name: biopsy needle
Regulation Number: 876.1075
Classification Product Code: FCG
Date Received: 04/02/2015
Decision Date: 05/01/2015
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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