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FDA 510(k), K193424, Resolution 360™ ULTRA Clip
FDA 510(k), K193424, Resolution 360™ ULTRA Clip
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510(K) Number: K193424
Device Name: Resolution 360™ ULTRA Clip
Manufacturer: Elena Hennessey
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: PKL
Classification Product Code: 12/10/2019
Date Received: 09/01/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Resolution 360™ ULTRA Clip
Manufacturer: Elena Hennessey
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: PKL
Classification Product Code: 12/10/2019
Date Received: 09/01/2020
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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