FDA 510(k) Application Details - K142647

Device Classification Name System, Image Processing, Radiological

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510(K) Number K142647
Device Name System, Image Processing, Radiological
Applicant MINT MEDICAL GMBH
Friedrich-Elbert-Str.2
Dossenheim 69221 DE
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Contact Jochen Neuhaus
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/17/2014
Decision Date 04/13/2015
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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