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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 K161039
Device Name NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
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 Received04/13/2016
Decision Date 06/17/2016
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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