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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 K240256
Device Name Remunity System
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 Received01/31/2024
Decision Date 06/12/2024
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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