FDA 510(k), K171454, Interject Injection Therapy Needle Catheter
FDA 510(k), K171454, Interject Injection Therapy Needle Catheter
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510(K) Number: K171454
Device Name: Interject Injection Therapy Needle Catheter
Manufacturer: Boston Scientific Corporation
Device Classification Name: endoscopic injection needle, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FBK
Date Received: 05/17/2017
Decision Date: 07/07/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Interject Injection Therapy Needle Catheter
Manufacturer: Boston Scientific Corporation
Device Classification Name: endoscopic injection needle, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FBK
Date Received: 05/17/2017
Decision Date: 07/07/2017
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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