FDA 510(k) Application Details - K092917

Device Classification Name Unit, Operative Dental

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510(K) Number K092917
Device Name Unit, Operative Dental
Applicant CEFLA S.C.
110 E. GRANADA BLVD.
SUITE 207
ORMOND BEACH, FL 32176 US
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Contact BERTHOIN CLAUDE
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 09/22/2009
Decision Date 06/24/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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