FDA 510(k) Application Details - K170596

Device Classification Name	Scaler, Rotary   More FDA Info for this Device
510(K) Number	K170596
Device Name	Scaler, Rotary
Applicant	GENOSS Co. Ltd. 1F, Gyeonggi R&DB Center, 105 Gwanggyo-ro, Yeongton-gu, Suwon-si Suwon-si 443-270 KR Other 510(k) Applications for this Company
Contact	Hyeyoung Moon Other 510(k) Applications for this Contact
Regulation Number	872.4840   More FDA Info for this Regulation Number
Classification Product Code	ELB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2017
Decision Date	09/11/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review