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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Specific Transition Connectors
510(k) Number K151237
Device Name Nutrisafe 2- ENFit Adaptor
Applicant
Vygon
2750 Morris Rd.
Suite A200
Lansdale Montgomery,  PA  19446
Applicant Contact Jillian Mikovich
Correspondent
Vygon
2750 Morris Rd.
Suite A200
Lansdale Montgomery,  PA  19446
Correspondent Contact Jillian Mikovich
Regulation Number876.5980
Classification Product Code
PIO  
Date Received05/11/2015
Decision Date 02/09/2016
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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