FDA 510(k) Application Details - K970812

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K970812
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	PLANMECA OY ASENTAJANKATU 6 HELSINKI 00880 FI Other 510(k) Applications for this Company
Contact	LARS MORING 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	03/05/1997
Decision Date	08/05/1997
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