FDA 510(k) Application Details - K183540

Device Classification Name	More FDA Info for this Device
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 US Other 510(k) Applications for this Company
Contact	Tony Lair Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2018
Decision Date	04/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review