The following data is part of a premarket notification filed by Zhuhai Dr Medical Instruments Co., Ltd with the FDA for Dr Safety Syringe, Sterile Hypodermic Needle For Single Use.
| Device ID | K212226 |
| 510k Number | K212226 |
| Device Name: | DR Safety Syringe, Sterile Hypodermic Needle For Single Use |
| Classification | Syringe, Antistick |
| Applicant | Zhuhai DR Medical Instruments Co., Ltd Floor 4, Factory Building A, No.288, East Airport Road, Jinwan District Zhuhai, CN |
| Contact | Xu Jianhai |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-09-29 |