FDA 510(k) Application Details - K101039

Device Classification Name Collimator, Automatic, Radiographic

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510(K) Number K101039
Device Name Collimator, Automatic, Radiographic
Applicant SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
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Contact DON KARLE
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Regulation Number 892.1610

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Classification Product Code IZW
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Date Received 04/14/2010
Decision Date 09/20/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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