FDA 510(k) Application Details - K100854

Device Classification Name	Handpiece, Contra- And Right-Angle Attachment, Dental   More FDA Info for this Device
510(K) Number	K100854
Device Name	Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant	PREMIUM PLUS INTERNATIONAL LIMITED 33 WANG YIP STREET WEST YUEN LONG NT HONG KONG CN Other 510(k) Applications for this Company
Contact	DENNIS NG Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2010
Decision Date	12/09/2010
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