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FDA 510(k), K203630, BioGuard Air/Water and Suction Valves
FDA 510(k), K203630, BioGuard Air/Water and Suction Valves
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510(K) Number: K203630
Device Name: BioGuard Air/Water and Suction Valves
Manufacturer: STERIS Corporations
Device Classification Name: Endoscope Channel Accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 12/11/2020
Decision Date: 01/08/2021
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: BioGuard Air/Water and Suction Valves
Manufacturer: STERIS Corporations
Device Classification Name: Endoscope Channel Accessory
Regulation Number: 876.1500
Classification Product Code: ODC
Date Received: 12/11/2020
Decision Date: 01/08/2021
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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