FDA 510(k), K190182, Unity Subcutaneous Delivery System for Remodulin

FDA 510(k), K190182, Unity Subcutaneous Delivery System for Remodulin

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510(K) Number: K190182
Device Name: Unity Subcutaneous Delivery System for Remodulin
Manufacturer: DEKA Research & Development
Device Classification Name: pump, infusion
Regulation Number: 880.5725
Classification Product Code: FRN
Date Received: 02/01/2019
Decision Date: 05/06/2019
Regulation Medical Specialty: General Hospital

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