FDA 510(k) Application Details - K032022

Device Classification Name Digitizer, Image, Radiological

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510(K) Number K032022
Device Name Digitizer, Image, Radiological
Applicant PYRAMID MEDICAL, INC.
10940 PORTAL MEDICAL DR.
LOS ALAMITOS, CA 90720 US
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Contact CLAUDE BENNETT
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Regulation Number 892.2030

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Classification Product Code LMA
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Date Received 06/30/2003
Decision Date 09/02/2003
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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