FDA 510(k) Application Details - K010166

Device Classification Name	System, Applicator, Radionuclide, Manual   More FDA Info for this Device
510(K) Number	K010166
Device Name	System, Applicator, Radionuclide, Manual
Applicant	IMAGYN MEDICAL TECHNOLOGIES, INC. 8850 M-89 RICHLAND, MI 49083 US Other 510(k) Applications for this Company
Contact	JULIE POWELL 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	01/18/2001
Decision Date	12/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review