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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 K240946
Device Name Gastric Alimetry
Applicant
Alimetry , Ltd.
70 Symonds St.
Grafton,  NZ 1010
Applicant Contact Yarmut Yaara
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number876.1735
Classification Product Code
MYE  
Date Received04/05/2024
Decision Date 07/03/2024
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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