FDA 510(k), K191006, EasiSlush
FDA 510(k), K191006, EasiSlush
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510(K) Number: K191006
Device Name: EasiSlush
Manufacturer: Bridge to Life Ltd.
Device Classification Name: system, perfusion, kidney
Regulation Number: 876.5880
Classification Product Code: KDN
Date Received: 04/16/2019
Decision Date: 09/24/2019
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EasiSlush
Manufacturer: Bridge to Life Ltd.
Device Classification Name: system, perfusion, kidney
Regulation Number: 876.5880
Classification Product Code: KDN
Date Received: 04/16/2019
Decision Date: 09/24/2019
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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