FDA 510(k) Application Details - K042647

Device Classification Name System, Image Processing, Radiological

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510(K) Number K042647
Device Name System, Image Processing, Radiological
Applicant COACTIV, LLC
1100 LAKEVIEW BLVD
DENTON, TX 76208 US
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Contact CARL ALLETTO
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/28/2004
Decision Date 10/07/2004
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 Y
Expedited Review



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