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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K130834
Device Name R7
Applicant
Cefla S.C.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Cefla S.C.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number872.4850
Classification Product Code
ELC  
Subsequent Product Code
EIA  
Date Received03/26/2013
Decision Date 10/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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