FDA 510(k) Application Details - K011619

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K011619
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	PLANMECA OY 1250 GREENBRIAR SUITE A ADDISON, IL 60111 US Other 510(k) Applications for this Company
Contact	BOB PIENKOWSKI Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2001
Decision Date	06/29/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review