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FDA 510(k), K142564, JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
FDA 510(k), K142564, JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
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510(K) Number: K142564
Device Name: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
Manufacturer: JMS North America Corporation
Device Classification Name: Needle, Fistula
Regulation Number: 876.5540
Classification Product Code: FIE
Date Received: 09/11/2014
Decision Date: 12/23/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
Manufacturer: JMS North America Corporation
Device Classification Name: Needle, Fistula
Regulation Number: 876.5540
Classification Product Code: FIE
Date Received: 09/11/2014
Decision Date: 12/23/2014
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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