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FDA 510(k), K161467, HydraGuard 10 UltraFilter
FDA 510(k), K161467, HydraGuard 10 UltraFilter
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$149.00 USD
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$149.00 USD
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510(K) Number: K161467
Device Name: HydraGuard 10 UltraFilter
Manufacturer: JAMES SUMMERTON
Device Classification Name: System, Water Purification, General Medical Use
Regulation Number: NHV
Classification Product Code: 05/27/2016
Date Received: 12/22/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HydraGuard 10 UltraFilter
Manufacturer: JAMES SUMMERTON
Device Classification Name: System, Water Purification, General Medical Use
Regulation Number: NHV
Classification Product Code: 05/27/2016
Date Received: 12/22/2016
Decision Date: Substantially Equivalent (SESE)
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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