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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 K232925
Device Name Gastric Alimetry System
Applicant
Alimetry , Ltd.
70 Symonds St., Bioengineering House, Level 9
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 Received09/19/2023
Decision Date 11/17/2023
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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