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.
|Device Name:||Oral/Enteral Syringe|
|Classification||Enteral Syringes With Enteral Specific Connectors|
|Applicant||Shanghai Kindly Enterprise Development Group Co., Ltd No. 658 Gaochao Road Shanghai, CN 201803|
Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120
|CFR Regulation Number||876.5980 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|