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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K991537
Device Name SAMSUNG RAYPAX SYSTEM
Applicant
Samsung Sds Co., Ltd.
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Applicant Contact HERMAN OOSTERWJICK
Correspondent
Samsung Sds Co., Ltd.
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Correspondent Contact HERMAN OOSTERWJICK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received05/03/1999
Decision Date 07/06/1999
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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