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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
Applicant
Medifactia AB
Sahlgrenska Science Park
Medicinaregatan 8a
Gothenburg,  SE SE-413 90
Applicant Contact Diana Nystrom
Correspondent
Msquared Associates, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact Connie Qiu
Regulation Number876.1725
Classification Product Code
FFX  
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
Predetermined Change
Control Plan Authorized		 No
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