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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 K212954
Device Name G-Tech Wireless Patch System (WPS)
Applicant
G-Tech Medical
2495 Hospital Dr., Suite 300
Mountain View,  CA  94040
Applicant Contact Steve Axelrod
Correspondent
G-Tech Medical
2495 Hospital Dr., Suite 300
Mountain View,  CA  94040
Correspondent Contact Steve Axelrod
Regulation Number876.1735
Classification Product Code
MYE  
Date Received09/16/2021
Decision Date 01/10/2022
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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