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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K112863
Device Name ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN
Applicant
Acta Medical, LLC
929 Arbor Downs Dr.
Plano,  TX  75023
Applicant Contact AARON COMPTON
Correspondent
Acta Medical, LLC
929 Arbor Downs Dr.
Plano,  TX  75023
Correspondent Contact AARON COMPTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/30/2011
Decision Date 03/29/2012
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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