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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointesinal Lesion Software Detection System
510(k) Number K240044
Device Name CADDIE
Applicant
Odin Medical Limited
43-45 Foley Street
London,  GB W1W 7TS
Applicant Contact Luke Sampson
Correspondent
Odin Medical Limited
43-45 Foley Street
London,  GB W1W 7TS
Correspondent Contact Luke Sampson
Regulation Number876.1520
Classification Product Code
QNP  
Subsequent Product Code
SBX  
Date Received01/05/2024
Decision Date 07/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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