FDA 510(k) Application Details - K984030

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K984030
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	INTEGRA MEDICAL 11661 SAN VICENTE BLVD. LOS ANGELES, CA 90949 US Other 510(k) Applications for this Company
Contact	W. EDWARD JOHANSEN 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	11/12/1998
Decision Date	02/10/1999
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