FDA 510(k) Application Details - K083035

Device Classification Name	Dosimeter, Ionizing Radiation, Implanted   More FDA Info for this Device
510(K) Number	K083035
Device Name	Dosimeter, Ionizing Radiation, Implanted
Applicant	SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	SUZANNE SCHWALLER Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	NZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	11/13/2008
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