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FDA 510(k) Application Details - K023390
Device Classification Name
Camera, Focal Spot, Radiographic
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510(K) Number
K023390
Device Name
Camera, Focal Spot, Radiographic
Applicant
MBF SALES, LLC
7361 CALHOUN PLACE
SUITE 500
ROCKVILLE, MD 20855-2765 US
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Contact
EDUARDO MARCH
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Regulation Number
892.1940
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Classification Product Code
IXH
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More FDA Info for this Product Code
Date Received
10/09/2002
Decision Date
11/26/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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