FDA 510(k) Application Details - K955394

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K955394
Device Name Camera, Multi Format, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN, NJ 08830 US
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Contact AMY S HOSLER
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 11/24/1995
Decision Date 02/21/1996
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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