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FDA 510(k), K161304, EndoPur Filter
FDA 510(k), K161304, EndoPur Filter
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$49.00 USD
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510(K) Number: K161304
Device Name: EndoPur Filter
Manufacturer: Hollie Johnson
Device Classification Name: Subsystem, Water Purification
Regulation Number: FIP
Classification Product Code: KXA
Date Received: 05/10/2016
Decision Date: 03/02/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EndoPur Filter
Manufacturer: Hollie Johnson
Device Classification Name: Subsystem, Water Purification
Regulation Number: FIP
Classification Product Code: KXA
Date Received: 05/10/2016
Decision Date: 03/02/2017
Decision: Substantially Equivalent (SESE)
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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