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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K190182
Device Name Unity Subcutaneous Delivery System for Remodulin
Applicant
DEKA Research & Development
340 Commercial St.
Manchester,  NH  03101
Applicant Contact Brian Carney
Correspondent
DEKA Research & Development
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact Brian Carney
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/01/2019
Decision Date 05/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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