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510(k) K190182

Unity Subcutaneous Delivery System for Remodulin by DEKA Research & Development — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2019
Date Received
February 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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