FDA 510(k) Application Details - K231734

Device Classification Name	More FDA Info for this Device
510(K) Number	K231734
Device Name	STERiJECT Low Dead Space, STERiJECT The Invisible Needle
Applicant	TSK Laboratory International Japan KK 2-1-5 Hirayanagi-Cho Tochigi-Shi 328-0012 JP Other 510(k) Applications for this Company
Contact	Kana Ebina Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2023
Decision Date	03/08/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review