FDA 510(k) Application Details - K963743

Device Classification Name	System, Applicator, Radionuclide, Manual   More FDA Info for this Device
510(K) Number	K963743
Device Name	System, Applicator, Radionuclide, Manual
Applicant	MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. NORTHBROOK, IL 60062 US Other 510(k) Applications for this Company
Contact	MICHAEL PLISHKA Other 510(k) Applications for this Contact
Regulation Number	892.5650   More FDA Info for this Regulation Number
Classification Product Code	IWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1996
Decision Date	12/06/1996
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