FDA 510(k) Application Details - K972312

Device Classification Name Unit, X-Ray, Extraoral With Timer

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510(K) Number K972312
Device Name Unit, X-Ray, Extraoral With Timer
Applicant SIEMENS AG
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760 US
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Contact STEVEN CLARKE
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Regulation Number 872.1800

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Classification Product Code EHD
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Date Received 06/20/1997
Decision Date 09/15/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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