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FDA 510(k), K213833, SCOPE BUDDY PLUS Endoscope Flushing Aid
FDA 510(k), K213833, SCOPE BUDDY PLUS Endoscope Flushing Aid
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$149.00 USD
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510(K) Number: K213833
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: 12/09/2021
Decision Date: 01/14/2022
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: 12/09/2021
Decision Date: 01/14/2022
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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