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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Electrogastrography (Egg)
510(k) Number K252504
Device Name Gastric Alimetry
Applicant
Alimetry , Ltd.
70 Symonds St.
Grafton
Auckland,  NZ 1010
Applicant Contact Yaara Yarmut
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Lina Kontos
Regulation Number876.1735
Classification Product Code
MYE  
Date Received08/08/2025
Decision Date 12/05/2025
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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