FDA 510(k) Application Details - K070803

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070803
Device Name System, Image Processing, Radiological
Applicant ANATOMAGE, INC
111N. MARKET ST, STE 930
SAN JOSE, CA 95113 US
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Contact ROBERT J CHIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/23/2007
Decision Date 04/06/2007
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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