FDA 510(k) Application Details - K991826

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K991826
Device Name	System, X-Ray, Mammographic
Applicant	PLANMED OY 362, BALM COURT WOOD DALE, IL 60191 US Other 510(k) Applications for this Company
Contact	BOB PIENKOWSKI Other 510(k) Applications for this Contact
Regulation Number	892.1710   More FDA Info for this Regulation Number
Classification Product Code	IZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/1999
Decision Date	08/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review