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FDA 510(k) Application Details - K013419
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K013419
Device Name
System, Image Processing, Radiological
Applicant
NICOLET BIOMEDICAL
6355 JOYCE DR.
GOLDEN, CO 80403 US
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Contact
DAVID W WAGNER
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
10/15/2001
Decision Date
12/20/2001
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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