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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K992131
Device Name SAMSUNG RAYPAX LONG TERM ARCHIVE
Applicant
Samsung Sds Co., Ltd.
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Applicant Contact CARL ALLETTO
Correspondent
Samsung Sds Co., Ltd.
2001 E. Oak Shores Dr.
Aubrey,  TX  76227
Correspondent Contact CARL ALLETTO
Regulation Number892.2010
Classification Product Code
LMB  
Date Received06/23/1999
Decision Date 09/13/1999
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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