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FDA 510(k) Application Details - K023513
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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