FDA 510(k) Application Details - K962105

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K962105
Device Name	System, X-Ray, Mammographic
Applicant	PLANMED 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	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	05/31/1996
Decision Date	02/05/1997
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