Oral/Enteral Syringe

Enteral Syringes With Enteral Specific Connectors

Shanghai Kindly Enterprise Development Group Co., Ltd

The following data is part of a premarket notification filed by Shanghai Kindly Enterprise Development Group Co., Ltd with the FDA for Oral/enteral Syringe.

Pre-market Notification Details

Device IDK192179
510k NumberK192179
Device Name:Oral/Enteral Syringe
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Shanghai Kindly Enterprise Development Group Co., Ltd No. 658 Gaochao Road Shanghai,  CN 201803
ContactWeixin Zhang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2020-05-01

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