FDA 510(k) Application Details - K080438

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K080438
Device Name	Unit, Operative Dental
Applicant	NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. # 19, LANE 999 ZHONGSHAN 2 RD SUITE 8D SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	DIANA HONG Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2008
Decision Date	04/04/2008
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	Y
Expedited Review