FDA 510(k) Application Details - K073369

Device Classification Name	Gutta-Percha   More FDA Info for this Device
510(K) Number	K073369
Device Name	Gutta-Percha
Applicant	HU-FRIEDY MFG. CO., INC 3232 N. ROCKWELL STREET CHICAGO, IL 60618 US Other 510(k) Applications for this Company
Contact	KEITH DUNN Other 510(k) Applications for this Contact
Regulation Number	872.3850   More FDA Info for this Regulation Number
Classification Product Code	EKM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2007
Decision Date	02/27/2008
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	N
Expedited Review