ANESTHESIA INJECTION TOOL SET

Syringe, Cartridge

KI WORKS CO., LTD.

The following data is part of a premarket notification filed by Ki Works Co., Ltd. with the FDA for Anesthesia Injection Tool Set.

Pre-market Notification Details

Device IDK113247
510k NumberK113247
Device Name:ANESTHESIA INJECTION TOOL SET
ClassificationSyringe, Cartridge
Applicant KI WORKS CO., LTD. MIGUN TECHNOWOLRD 2 C-DONG 524 #533-1 Yongsan-dong, Daejeon,  KR Ks
ContactEileen Yang
CorrespondentEileen Yang
KI WORKS CO., LTD. MIGUN TECHNOWOLRD 2 C-DONG 524 #533-1 Yongsan-dong, Daejeon,  KR Ks
Product CodeEJI  
CFR Regulation Number872.6770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-02
Decision Date2012-03-27
Summary:summary

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.