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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 K152857
FOIA Releasable 510(k) K152857
Device Name NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
Applicant
Neomed, Inc.
100 Londonderry Ct., Suite 112
Woodstock,  GA  30188
Applicant Contact TONY LAIR
Correspondent
Neomed, Inc.
100 Londonderry Ct., Suite 112
Woodstock,  GA  30188
Correspondent Contact MELINDA HARRISON SMITH
Regulation Number876.5980
Classification Product Code
PNR  
Date Received09/30/2015
Decision Date 12/17/2015
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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