FDA 510(k), K192059, Bio Guard Air/Water & Suction Valves
FDA 510(k), K192059, Bio Guard Air/Water & Suction Valves
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510(K) Number: K192059
Device Name: Bio Guard Air/Water & Suction Valves
Manufacturer: United States Endoscopy Group, Inc.
Device Classification Name: Endoscope Channel Accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 08/01/2019
Decision Date: 09/17/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Bio Guard Air/Water & Suction Valves
Manufacturer: United States Endoscopy Group, Inc.
Device Classification Name: Endoscope Channel Accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 08/01/2019
Decision Date: 09/17/2019
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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