The following data is part of a premarket notification filed by Shanghai Kohope Medical Devices Co., Ltd with the FDA for Sterile Hypodermic Syringe For Single Use, With/without Needle, Sterile Insulin Syringe For Single Use, With Needle, Sterile Hypodermic Needle For Single Use.
| Device ID | K190002 |
| 510k Number | K190002 |
| Device Name: | Sterile Hypodermic Syringe For Single Use, With/without Needle, Sterile Insulin Syringe For Single Use, With Needle, Sterile Hypodermic Needle For Single Use |
| Classification | Syringe, Piston |
| Applicant | Shanghai Kohope Medical Devices Co., Ltd Room 1001, No.2 Building, Lane 2888 South Qilian Mountains Road Shanghai, CN 200331 |
| Contact | Yibing Wang |
| Correspondent | Diana Hong Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-09-12 |
| Summary: | summary |