FDA 510(k) Application Details - K021245

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K021245
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	THE GOTZEN GROUP, INC. 30 ALDEN TERRACE FLANDERS, NJ 07836 US Other 510(k) Applications for this Company
Contact	DONALD R HILL 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	04/19/2002
Decision Date	05/03/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review