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FDA 510(k) Applications Submitted by DEKA RESEARCH & DEVELOPMENT
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190182
02/01/2019
Unity Subcutaneous Delivery System for Remodulin
DEKA Research & Development
K191313
05/15/2019
Unity Subcutaneous Infusion System for Remodulin
DEKA Research & Development
K153760
12/30/2015
Volumetric Infusion Controller
DEKA RESEARCH & DEVELOPMENT
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