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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 K061114
Device Name WDS, SIZE 2 AND SIZE 2
Applicant
Cefla S.C.R.L.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Cefla S.C.R.L.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/21/2006
Decision Date 06/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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