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
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
- 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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