FDA 510(k) Application Details - K183316

Device Classification Name	Needle, Conduction, Anesthetic (W/Wo Introducer)   More FDA Info for this Device
510(K) Number	K183316
Device Name	Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant	Dr. Japan Co., Ltd. 1-1 Kagurazaka, Shinjuku-ku Tokyo 162-0825 JP Other 510(k) Applications for this Company
Contact	Mitsuko Uchida Other 510(k) Applications for this Contact
Regulation Number	868.5150   More FDA Info for this Regulation Number
Classification Product Code	BSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2018
Decision Date	08/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review