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FDA 510(k), K161463, SureClip(TM) Repositionable Hemostasis Clip
FDA 510(k), K161463, SureClip(TM) Repositionable Hemostasis Clip
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$149.00 USD
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510(K) Number: K161463
Device Name: SureClip(TM) Repositionable Hemostasis Clip
Manufacturer: Becky Li
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: PKL
Classification Product Code: 05/26/2016
Date Received: 01/06/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SureClip(TM) Repositionable Hemostasis Clip
Manufacturer: Becky Li
Device Classification Name: Hemostatic Metal Clip For The Gi Tract
Regulation Number: PKL
Classification Product Code: 05/26/2016
Date Received: 01/06/2017
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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