FDA 510(k) Application Details - K002195

Device Classification Name	Locator, Root Apex   More FDA Info for this Device
510(K) Number	K002195
Device Name	Locator, Root Apex
Applicant	PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 FARMINGDALE, NY 11735 US Other 510(k) Applications for this Company
Contact	DANIEL R SCHECHTER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/20/2000
Decision Date	08/30/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review