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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 South Broad Street, 17th Floor
Philadelphia,  PA  19102
Applicant Contact William Brown
Correspondent
Libra Medical, Inc.
8401 73rd Ave North, Suite 63
Brooklyn Park,  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
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