FDA 510(k) Application Details - K971452

Device Classification Name Table, Radiographic, Non-Tilting, Powered

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510(K) Number K971452
Device Name Table, Radiographic, Non-Tilting, Powered
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN, NJ 08830 US
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Contact JEFFREY W KOONTZ
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Regulation Number 892.1980

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Classification Product Code IZZ
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Date Received 04/21/1997
Decision Date 05/14/1997
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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