FDA 510(k) Application Details - K140202

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K140202
Device Name	Implant, Endosseous, Root-Form
Applicant	JIANGSU TRAUSIM MEDICAL INSTRUMENT WEST RENMIN RD., NIUTANG TOWN, WUJIN DIST. CHANGZHOU CITY, JAINGSU PROVICNE 213163 CN Other 510(k) Applications for this Company
Contact	LUO ZHICONG Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2014
Decision Date	12/12/2014
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