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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 K250930
Device Name twiist system
Applicant
Deka Research & Development Corp.
340 Commercial St.
Manchester,  NH  03101
Applicant Contact William Calhoun
Correspondent
Deka Research & Development Corp.
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact William Calhoun
Regulation Number880.5730
Classification Product Code
QFG  
Date Received03/28/2025
Decision Date 04/02/2025
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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