FDA 510(k) Application Details - K973125

Device Classification Name Processor, Radiographic-Film, Automatic

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510(K) Number K973125
Device Name Processor, Radiographic-Film, Automatic
Applicant C.M.A.
7916 KETTLEWOOD CT.
PLANO, TX 75025 US
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Contact CARL ALLETTO
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Regulation Number 892.1900

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Classification Product Code IXW
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Date Received 08/20/1997
Decision Date 10/08/1997
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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