FDA 510(k) Application Details - K072867

Device Classification Name System, X-Ray, Stationary

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510(K) Number K072867
Device Name System, X-Ray, Stationary
Applicant IMIX ADR FINLAND OY
75 ORCHARD SPRING ESTS
WATERBURY, VT 05676 US
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Contact JAMES TAYLOR
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 10/05/2007
Decision Date 11/21/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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