FDA 510(k) Application Details - K100272

Device Classification Name Display, Cathode-Ray Tube, Medical

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510(K) Number K100272
Device Name Display, Cathode-Ray Tube, Medical
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact TERESA SCHMIDT
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Regulation Number 870.2450

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Classification Product Code DXJ
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Date Received 01/29/2010
Decision Date 04/14/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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