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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusion Pump, Drug Specific, Pharmacy-Filled
510(k) Number K202690
Device Name Remunity Pump for Remodulin (treprostinil) Injection
Applicant
DEKA Research and Development
340 Commercial Street
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
DEKA Research and Development
340 Commercial Street
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number880.5725
Classification Product Code
QJY  
Date Received09/15/2020
Decision Date 12/30/2020
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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