FDA 510(k) Application Details - K014300

Device Classification Name	Sheet, Recording, Breast Examination   More FDA Info for this Device
510(K) Number	K014300
Device Name	Sheet, Recording, Breast Examination
Applicant	JAMES D RUSIN MD, MBA 3512 RUM RIVER DR. ANOKA, MN 55303-1109 US Other 510(k) Applications for this Company
Contact	JAMES D RUSIN Other 510(k) Applications for this Contact
Regulation Number	884.2990   More FDA Info for this Regulation Number
Classification Product Code	NHM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2001
Decision Date	03/01/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review