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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alternate Controller Enabled Insulin Infusion Pump
510(k) Number K241178
Device Name DEKA ACE Pump System
Applicant
Deka Research and Development
340 Commercial St.
Manchester,  NH  03101
Applicant Contact Paul Smolenski
Correspondent
Deka Research and Development
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact Paul Smolenski
Regulation Number880.5730
Classification Product Code
QFG  
Subsequent Product Code
NDC  
Date Received04/29/2024
Decision Date 05/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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