FDA 510(k) Application Details - K242073

Device Classification Name	More FDA Info for this Device
510(K) Number	K242073
Device Name	STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
Applicant	TSK Laboratory International Japan KK 2-1-5 Hirayanagi-Cho Tochigi-Shi 328-0012 JP Other 510(k) Applications for this Company
Contact	Seika Shiba Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2024
Decision Date	10/23/2024
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