Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082921
Device Classification Name
Irradiator, Blood To Prevent Graft Versus Host Disease
More FDA Info for this Device
510(K) Number
K082921
Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Applicant
RAD SOURCE TECHNOLOGIES, INC.
6825 SHILOH ROAD EAST
SUITE B2
ALPHARETTA, GA 30005 US
Other 510(k) Applications for this Company
Contact
RANDOL E KIRK
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MOT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2008
Decision Date
02/17/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact