FDA 510(k) Application Details - K083569

Device Classification Name Drill, Bone, Powered

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510(K) Number K083569
Device Name Drill, Bone, Powered
Applicant SILFRADENT S.R.L.
110 E. GRANADA BLVD., STE. 207
ORMOND BEACH, FL 32176 US
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Contact CLAUDE D BERTHOIN
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Regulation Number 872.4120

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Classification Product Code DZI
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Date Received 12/03/2008
Decision Date 04/01/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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