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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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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