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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K211661
Device Name ENFit enteral syringes (NUTRIFIT)
Applicant
Pentaferte Italia S.R.L.
Viale Piane Nocella, 23
Campli,  IT i-64012
Applicant Contact Rosa Di Gioia
Correspondent
Vygon USA
2750 Morris Rd.
Suite A200
Lansdale Montgomery,  PA  19446
Correspondent Contact Stephanie Rose
Regulation Number876.5980
Classification Product Code
PNR  
Date Received06/01/2021
Decision Date 02/28/2022
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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