• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit, by Bayer Medical Care, Inc.

FDA 510(k) K143538, MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit, by Bayer Medical Care, Inc.

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$1,441.01 USD
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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

787 pages (23,381 of 24,168 original pages are fully redacted)
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