FDA 510(k) Application Details - K072898

Device Classification Name Couch, Radiation Therapy, Powered

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510(K) Number K072898
Device Name Couch, Radiation Therapy, Powered
Applicant MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
ROBERT-BOSCH-STRASSE 8
SCHWABMUNCHEN 86830 DE
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Contact MICHAEL WOLFF
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Regulation Number 892.5770

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Classification Product Code JAI
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Date Received 10/11/2007
Decision Date 10/25/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party Y
Expedited Review



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