FDA 510(k) Application Details - K052422

Device Classification Name	Unit, X-Ray, Intraoral   More FDA Info for this Device
510(K) Number	K052422
Device Name	Unit, X-Ray, Intraoral
Applicant	FLOW X-RAY CORP. 55 NORTHEREN BLVD., SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	872.1810   More FDA Info for this Regulation Number
Classification Product Code	EAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2005
Decision Date	09/27/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review