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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name collector, ostomy
510(k) Number K181643
Device Name SmartBag (SmartPouch)
Applicant
11 Health Technologies Limited
The Kinetic Business Centre, Theobald Street
Borehamwood,  GB WD6 4PJ
Applicant Contact Michael Seres
Correspondent
11 Health Technologies Limited
The Kinetic Business Centre, Theobald Street
Borehamwood,  GB WD6 4PJ
Correspondent Contact Priya Woodun
Regulation Number876.5900
Classification Product Code
EXB  
Subsequent Product Codes
EZQ   EZS   LHQ  
Date Received06/22/2018
Decision Date 11/16/2018
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
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