FDA 510(k) Application Details - K083274

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K083274
Device Name	Source, Brachytherapy, Radionuclide
Applicant	BIOCOMPATIBLES, INC. 115 HURLEY ROAD OXFORD, CT 06474 US Other 510(k) Applications for this Company
Contact	WAYNE RICHARDSON 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	11/06/2008
Decision Date	01/08/2009
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