FDA 510(k) Application Details - K023513

Device Classification Name Unit, Operative Dental

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510(K) Number K023513
Device Name Unit, Operative Dental
Applicant CASTELLINI S.P.A.
VIA SALICETO 22
CASTEL MAGGIORE, BOLOGNA 40013 IT
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Contact GIULIANO LANZARINI
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 10/21/2002
Decision Date 03/26/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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