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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, operative dental
510(k) Number K133412
Device Name S200, S300
Applicant
CEFLA S.C.
110 E. GRANADA BLVD. SUITE 207
ORMOND BEACH,  FL  32176
Applicant Contact BERTHOIN CLAUDE
Correspondent
CEFLA S.C.
110 E. GRANADA BLVD. SUITE 207
ORMOND BEACH,  FL  32176
Correspondent Contact BERTHOIN CLAUDE
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/07/2013
Decision Date 01/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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