FDA 510(k) Application Details - K073124

Device Classification Name Collimator, Automatic, Radiographic

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510(K) Number K073124
Device Name Collimator, Automatic, Radiographic
Applicant COLLIMARE, LLC
13406 W 60TH PL
ARVADA, CO 80004 US
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Contact HOWARD C THOMAS
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Regulation Number 892.1610

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Classification Product Code IZW
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Date Received 11/06/2007
Decision Date 11/16/2007
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 Y
Expedited Review



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