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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 K183540
Device Name Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
Applicant
Neomed, Inc.
100 Londonderry Ct, Suite 112
Woodstock,  GA  30188
Applicant Contact Tony Lair
Correspondent
Neomed, Inc.
100 Londonderry Court, Suite 112
Woodstock,  GA  30188
Correspondent Contact Melinda Smith
Regulation Number876.5980
Classification Product Code
PNR  
Date Received12/20/2018
Decision Date 04/30/2019
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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