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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K133007
Device Name DX3000-L
Applicant
Dexcowin Co., Ltd.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Dexcowin Co., Ltd.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/25/2013
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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