The following data is part of a premarket notification filed by Ki Works Co., Ltd. with the FDA for Anesthesia Injection Tool Set.
| Device ID | K113247 |
| 510k Number | K113247 |
| Device Name: | ANESTHESIA INJECTION TOOL SET |
| Classification | Syringe, Cartridge |
| Applicant | KI WORKS CO., LTD. MIGUN TECHNOWOLRD 2 C-DONG 524 #533-1 Yongsan-dong, Daejeon, KR Ks |
| Contact | Eileen Yang |
| Correspondent | Eileen Yang KI WORKS CO., LTD. MIGUN TECHNOWOLRD 2 C-DONG 524 #533-1 Yongsan-dong, Daejeon, KR Ks |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2012-03-27 |
| Summary: | summary |