FDA 510(k) Application Details - K070618

Device Classification Name System, Image Processing, Radiological

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510(K) Number K070618
Device Name System, Image Processing, Radiological
Applicant OEHM UND REHBEIN GMBH
WALDEMSRSTR. 20G/H
ROCKSTOCK 18057 DE
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Contact FRANZISKA GUNTHER
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/05/2007
Decision Date 04/25/2007
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 N
Expedited Review



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