FDA 510(k) Application Details - K192561

Device Classification Name	Drill, Bone, Powered   More FDA Info for this Device
510(K) Number	K192561
Device Name	Drill, Bone, Powered
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	DongHa Lee Other 510(k) Applications for this Contact
Regulation Number	872.4120   More FDA Info for this Regulation Number
Classification Product Code	DZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2019
Decision Date	07/13/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review