FDA 510(k) Application Details - K072766

Device Classification Name System, Imaging, X-Ray, Electrostatic

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510(K) Number K072766
Device Name System, Imaging, X-Ray, Electrostatic
Applicant PORTAVISION MEDICAL
1705 S. CAPITAL OF TEXAS HWY.
SUITE 500
AUSTIN, TX 78746 US
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Contact IAN GORDEN
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Regulation Number 892.1630

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Classification Product Code IXK
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Date Received 09/28/2007
Decision Date 12/11/2007
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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