Disposable Enteral Feeding Syringe With Enfit Connector

Enteral Syringes With Enteral Specific Connectors

Shinva Ande Healthcare Apparatus Co., Ltd.

The following data is part of a premarket notification filed by Shinva Ande Healthcare Apparatus Co., Ltd. with the FDA for Disposable Enteral Feeding Syringe With Enfit Connector.

Pre-market Notification Details

Device IDK193657
510k NumberK193657
Device Name:Disposable Enteral Feeding Syringe With Enfit Connector
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road Zibo,  CN 255086
ContactXiaolei Tian
CorrespondentMike Gu
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Quinglan Street, Panyu District Guangzhou,  CN 510006
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-09-12

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