FDA 510(k) Application Details - K191313

Device Classification Name	More FDA Info for this Device
510(K) Number	K191313
Device Name	Unity Subcutaneous Infusion System for Remodulin
Applicant	DEKA Research & Development 340 Commercial Street Manchester, NH 03101 US Other 510(k) Applications for this Company
Contact	Jason Demers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2019
Decision Date	02/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review