FDA 510(k) Application Details - K972215

Device Classification Name System, Image Processing, Radiological

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510(K) Number K972215
Device Name System, Image Processing, Radiological
Applicant VEPRO - COMPUTERSYSTEME GMBH
AN DER TUCHBLEICHE 26
PFUNGSTADT D-64319 DE
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Contact HARALD G ROTH
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 06/13/1997
Decision Date 11/19/1997
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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