FDA 510(k) Application Details - K171577

Device Classification Name	Cord, Retraction   More FDA Info for this Device
510(K) Number	K171577
Device Name	Cord, Retraction
Applicant	EASTDENT Co., Ltd 601-1 Sogong B/D, 64 Gugal-ro, Giheung-gu Yongin-si 16972 KR Other 510(k) Applications for this Company
Contact	Hyonsu Kim Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MVL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2017
Decision Date	05/03/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review