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FDA 510(k) Application Details - K061855
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K061855
Device Name
System, Image Processing, Radiological
Applicant
CORTECHS LABS, INC
1020 PROSPECT ST., SUITE 304
LA JOLLA, CA US
Other 510(k) Applications for this Company
Contact
ALLAN GREEN
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2006
Decision Date
08/10/2006
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
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