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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 K230545
Device Name Inessa System
Applicant
Triple Jump Israel , Ltd.
5 Hacarmel St., P.O.B. 205
Yokneam Lllit,  IL 2069203
Applicant Contact Liron Hadar
Correspondent
Hogan Lovells US LLP
1735 Market St.
Philladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number880.5730
Classification Product Code
QFG  
Subsequent Product Code
NDC  
Date Received02/28/2023
Decision Date 12/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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