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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orally Ingested Transient Device For Constipation
510(k) Number K232830
Device Name Vibrant System
Applicant
Vibrant, Ltd.
Hakochav Pob 516
Yokneam,  IL 2069206
Applicant Contact Martha Bezalel, Ph.D.
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice Hogan
Classification Product Code
QTN  
Date Received09/13/2023
Decision Date 12/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05036369
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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