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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K102321
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
Applicant
Samsung Mobile Display Co., Ltd.
333 Meadowlands Pkwy.,
#303
Secaucus,  NJ  07094
Applicant Contact DAVE KIM
Correspondent
Samsung Mobile Display Co., Ltd.
333 Meadowlands Pkwy.,
#303
Secaucus,  NJ  07094
Correspondent Contact DAVE KIM
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/17/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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