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 |