FDA 510(k) Application Details - K992335

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K992335
Device Name System, Tomography, Computed, Emission
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
HIGHLAND HEIGHTS, OH 44143 US
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Contact RONALD J MARTONE
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 07/13/1999
Decision Date 10/07/1999
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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