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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K023513
Device Name LOGOS JUNIOR DENTAL CHAIR AND UNIT
Applicant
Castellini S.P.A.
Via Saliceto 22
Castel Maggiore, Bologna,  IT 40013
Applicant Contact GIULIANO LANZARINI
Correspondent
Castellini S.P.A.
Via Saliceto 22
Castel Maggiore, Bologna,  IT 40013
Correspondent Contact GIULIANO LANZARINI
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/21/2002
Decision Date 03/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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