FDA 510(k) Application Details - K170697

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K170697
Device Name	Plate, Bone
Applicant	SURGIDENT #209~210, Woolim LionÆs Valley, 27 Dunchon-daero 457 beon-gil, Jungwon-gu Seongnam-si 13219 KR Other 510(k) Applications for this Company
Contact	Duck-su Hur Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2017
Decision Date	05/24/2018
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