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FDA 510(k), K173919, HX Device
FDA 510(k), K173919, HX Device
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510(K) Number: K173919
Device Name: HX Device
Manufacturer: Human Extension Ltd.
Device Classification Name: laparoscope, general & plastic surgery
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 12/22/2017
Decision Date: 03/20/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HX Device
Manufacturer: Human Extension Ltd.
Device Classification Name: laparoscope, general & plastic surgery
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 12/22/2017
Decision Date: 03/20/2018
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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