FDA 510(k) Application Details - K111465

Device Classification Name	Instruments, Dental Hand   More FDA Info for this Device
510(K) Number	K111465
Device Name	Instruments, Dental Hand
Applicant	KERRHAWE SA 1717 WEST COLLINS AVENUE ORANGE, CA 92867 US Other 510(k) Applications for this Company
Contact	Wendy Garman Other 510(k) Applications for this Contact
Regulation Number	872.4565   More FDA Info for this Regulation Number
Classification Product Code	DZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2011
Decision Date	07/25/2012
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