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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K243841
Device Name Sparta Infusion Set for Insulin
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 Number880.5440
Classification Product Code
FPA  
Date Received12/13/2024
Decision Date 08/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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