FDA 510(k) Application Details - K233153

Device Classification Name	Motor, Drill, Electric   More FDA Info for this Device
510(K) Number	K233153
Device Name	Motor, Drill, Electric
Applicant	Saeshin Precision Co., Ltd. #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu 42921 KR Other 510(k) Applications for this Company
Contact	Gung San Nam Other 510(k) Applications for this Contact
Regulation Number	882.4360   More FDA Info for this Regulation Number
Classification Product Code	HBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	09/20/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review