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 ID | K192179 |
| 510k Number | K192179 |
| 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 |
| Contact | Weixin Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2020-05-01 |