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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K002062
Device Name SAMSUNG 10DR IMPLANT SYSTEM
Applicant
SAMSUNG SDS CO., LTD
2001 EAST OAKSHORES DR.
AUBREY,  TX  76227
Applicant Contact CARL ALLETTO
Correspondent
SAMSUNG SDS CO., LTD
2001 EAST OAKSHORES DR.
AUBREY,  TX  76227
Correspondent Contact CARL ALLETTO
Regulation Number872.1800
Classification Product Code
EHD  
Date Received07/06/2000
Decision Date 11/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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