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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 K250357
Device Name RemunityPRO™ Pump for Remodulin® (treprostinil) Injection
Applicant
Deka Research & Development Corp.
340 Commercial St.
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
Deka Research & Development Corp.
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/07/2025
Decision Date 03/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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