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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 K223398
Device Name Gastric Alimetry System
Applicant
Alimetry , Ltd.
70 Symonds St.
Grafton,  NZ 1010
Applicant Contact Yaara Yarmut
Correspondent
Hogan Lovells US LLP
1735 Market St., Floor 23
Philadelphia,  PA  19115
Correspondent Contact Janice Hogan
Regulation Number876.1735
Classification Product Code
MYE  
Date Received11/08/2022
Decision Date 04/27/2023
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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