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FDA 510(k), K162128, Scope Buddy Plus Endoscope Flushing Aid
FDA 510(k), K162128, Scope Buddy Plus Endoscope Flushing Aid
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$149.00 USD
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510(K) Number: K162128
Device Name: Scope Buddy Plus Endoscope Flushing Aid
Manufacturer: MEDIVATORS INC.
Device Classification Name: Accessories, Cleaning, For Endoscope
Regulation Number: 876.1500
Classification Product Code: FEB
Date Received: 08/01/2016
Decision Date: 12/21/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Scope Buddy Plus Endoscope Flushing Aid
Manufacturer: MEDIVATORS INC.
Device Classification Name: Accessories, Cleaning, For Endoscope
Regulation Number: 876.1500
Classification Product Code: FEB
Date Received: 08/01/2016
Decision Date: 12/21/2016
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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