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FDA 510(k) Application Details - K110300
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K110300
Device Name
System, Image Processing, Radiological
Applicant
MATERIALISE DENTAL NV
TECHNOLOGIELAAN 15
LEUVEN 3001 BE
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Contact
PETER VANDEPUT
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
02/02/2011
Decision Date
07/01/2011
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
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