ENFit Reusable Enteral Syringe

Enteral Syringes With Enteral Specific Connectors

Shantou Wealy Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Shantou Wealy Medical Instrument Co., Ltd. with the FDA for Enfit Reusable Enteral Syringe.

Pre-market Notification Details

Device IDK203613
510k NumberK203613
Device Name:ENFit Reusable Enteral Syringe
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road (near Qishan Mid-school), Shantou China Shantou,  CN 515064
ContactYang Songling
CorrespondentEva Li
Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai,  CN 200122
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-08-27

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