FDA 510(k), K192908, Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
FDA 510(k), K192908, Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
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510(K) Number: K192908
Device Name: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
Manufacturer: Wilson-Cook Medical, Inc
Device Classification Name: Endoscopic Cytology Brush
Regulation Number: 876.1500
Classification Product Code: FDX
Date Received: 10/15/2019
Decision Date: 11/14/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
Manufacturer: Wilson-Cook Medical, Inc
Device Classification Name: Endoscopic Cytology Brush
Regulation Number: 876.1500
Classification Product Code: FDX
Date Received: 10/15/2019
Decision Date: 11/14/2019
Regulation Medical Specialty: Gastroenterology/Urology
- 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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