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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 K181760
Device Name Transit-Pellets
Medifactia AB
Sahlgrenska Science Park
Medicinaregatan 8A
Gothenburg,  SE SE-413 90
Applicant Contact Diana Nystrom
M Squared Associates, Inc.
575 8th Avenue, Suite 1212
New York,  NY  10018
Correspondent Contact Connie Qiu
Regulation Number876.1725
Classification Product Code
Date Received07/03/2018
Decision Date 08/08/2019
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