FDA 510(k), K182556, SureClip Repositionable Hemostasis Clip
FDA 510(k), K182556, SureClip Repositionable Hemostasis Clip
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510(K) Number: K182556
Device Name: SureClip Repositionable Hemostasis Clip
Manufacturer: Micro-Tech (Nanjing) CO., Ltd.
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 09/17/2018
Decision Date: 12/14/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: SureClip Repositionable Hemostasis Clip
Manufacturer: Micro-Tech (Nanjing) CO., Ltd.
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 09/17/2018
Decision Date: 12/14/2018
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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