The following data is part of a premarket notification filed by Jeesung Medical Co., Ltd. with the FDA for Jeesung Safety Syringe And Single Use Needles.
| Device ID | K212518 |
| 510k Number | K212518 |
| Device Name: | Jeesung Safety Syringe And Single Use Needles |
| Classification | Syringe, Antistick |
| Applicant | JeeSung Medical Co., Ltd. 54, Mujini 1-gil, Daedeok-gu Daejeon, KR 34340 |
| Contact | Choi Yong Hyun |
| Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2022-08-18 |