FDA 510(k) Application Details - K992262

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K992262
Device Name	Source, Brachytherapy, Radionuclide
Applicant	INDIGO MEDICAL, INC. 10123 ALLIANCE RD. CINCINNATI, OH 45242 US Other 510(k) Applications for this Company
Contact	JACQUELYN A HUGHES Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	KXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/1999
Decision Date	10/04/1999
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