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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K113247
Device Name ANESTHESIA INJECTION TOOL SET
Applicant
Ki Works Co., Ltd.
Migun Technowolrd 2
C-Dong 524 #533-1
Yongsan-Dong, Daejeon,  KR KS
Applicant Contact EILEEN YANG
Correspondent
Ki Works Co., Ltd.
Migun Technowolrd 2
C-Dong 524 #533-1
Yongsan-Dong, Daejeon,  KR KS
Correspondent Contact EILEEN YANG
Regulation Number872.6770
Classification Product Code
EJI  
Date Received11/02/2011
Decision Date 03/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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