FDA 510(k) Application Details - K081884

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K081884
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant MAJOR PRODOTTI DENTARI S.P.A.
VIA LUIGI EINAUDI 23
MONACALIERI (TORINO) I-10024 IT
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Contact MONICA FUNAI
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 07/02/2008
Decision Date 10/08/2008
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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