FDA 510(k) Application Details - K102587

Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)

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510(K) Number K102587
Device Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant SAMSUNG MOBILE DISPLAY CO., LTD
333 MEADOWLANDS PKWY
#303
SECAUCUS, NJ 07094 US
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Contact DAVE KIM
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Regulation Number 892.1650

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Classification Product Code MQB
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Date Received 09/09/2010
Decision Date 12/01/2010
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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