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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K222000
Device Name Transit-Pellets
Medifactia AB
C/O IOffice Buisness Center Kungsgatan 60
Stockholm,  SE 11122
Applicant Contact Diana Nystrom
M Squared Associates Inc.
127 West 30th Street
9th Floor
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number876.1725
Classification Product Code
Date Received07/07/2022
Decision Date 01/18/2023
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