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FDA 510(k), K180481, Servator B SALF Solution
FDA 510(k), K180481, Servator B SALF Solution
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510(K) Number: K180481
Device Name: Servator B SALF Solution
Manufacturer: Carmelo Gagliano
Device Classification Name: System, Perfusion, Kidney
Regulation Number: KDN
Classification Product Code: 02/23/2018
Date Received: 06/29/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Servator B SALF Solution
Manufacturer: Carmelo Gagliano
Device Classification Name: System, Perfusion, Kidney
Regulation Number: KDN
Classification Product Code: 02/23/2018
Date Received: 06/29/2018
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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