VR Medical Feeding Tube And Enteral Feeding Extension Set (EFES)

Tube, Feeding

VR MEDICAL TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Vr Medical Technology Co., Ltd with the FDA for Vr Medical Feeding Tube And Enteral Feeding Extension Set (efes).

Pre-market Notification Details

Device IDK180236
510k NumberK180236
Device Name:VR Medical Feeding Tube And Enteral Feeding Extension Set (EFES)
ClassificationTube, Feeding
Applicant VR MEDICAL TECHNOLOGY CO., LTD No. 90 Gaoxin Rd. Zhouzhuang,  CN 215325
ContactLee Pan
CorrespondentPaul Dryden
VR Medical C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeFPD  
Subsequent Product CodeKNT
Subsequent Product CodePIF
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-29
Decision Date2019-01-18
Summary:summary

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