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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K163586
Device Name Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
Applicant
Trovrx, Inc. Dba Trovita Health Science
230 S. Broad St., 17th Floor
Philadelphia,  PA  19102
Applicant Contact William Brown
Correspondent
Libramedical, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact Julie Bodmer
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received12/20/2016
Decision Date 03/17/2017
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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