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FDA 510(k), K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
FDA 510(k), K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
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510(K) Number: K143538
Device Name: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Manufacturer: BAYER MEDICAL CARE INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 12/15/2014
Decision Date: 08/14/2015
Regulation Medical Specialty: Cardiovascular
Device Name: MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
Manufacturer: BAYER MEDICAL CARE INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 12/15/2014
Decision Date: 08/14/2015
Regulation Medical Specialty: Cardiovascular
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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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