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FDA 510(k) Application Details - K955092
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K955092
Device Name
System, Image Processing, Radiological
Applicant
CEMAX-ICON, INC.
47281 MISSION FALLS CT.
FREMONT, CA 94539 US
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Contact
LINDA J MOORE
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
11/07/1995
Decision Date
05/09/1996
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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