FDA 510(k) Application Details - K031535

Device Classification Name System, X-Ray, Stationary

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510(K) Number K031535
Device Name System, X-Ray, Stationary
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98021-3003 US
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Contact LYNN T HARMER
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 05/16/2003
Decision Date 06/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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