FDA 510(k) Application Details - K983621

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K983621
Device Name	System, X-Ray, Mammographic
Applicant	REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. ALPHARETTA, GA 30005 US Other 510(k) Applications for this Company
Contact	STEVE WOODY 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	10/15/1998
Decision Date	11/03/1998
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