FDA 510(k) Application Details - K983436

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K983436
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	GAMMAMED USA 2464 EAST STADIUM WAY ANN ARBOR, MI 48104 US Other 510(k) Applications for this Company
Contact	JOHN J MUNRO III Other 510(k) Applications for this Contact
Regulation Number	892.5700   More FDA Info for this Regulation Number
Classification Product Code	JAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/1998
Decision Date	10/29/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review