510(k) K113247

ANESTHESIA INJECTION TOOL SET by Ki Works Co., Ltd. — Product Code EJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2012
Date Received
November 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type