FDA 510(k) Application Details - K991535

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K991535
Device Name System, Tomography, Computed, Emission
Applicant HITACHI MEDICAL CORP. OF AMERICA
9177 DUTTON DR.
TWINSBURG, OH 44056 US
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Contact GARY W ENOS
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 05/03/1999
Decision Date 07/30/1999
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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