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FDA 510(k), K220158, G-EYE System
FDA 510(k), K220158, G-EYE System
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$149.00 USD
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510(K) Number: K220158
Device Name: G-EYE System
Manufacturer: Smart Medical Systems Ltd.
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 01/19/2022
Decision Date: 04/11/2022
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: G-EYE System
Manufacturer: Smart Medical Systems Ltd.
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 01/19/2022
Decision Date: 04/11/2022
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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