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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K083473
Device Name CLEAR BRAVO
Applicant
Denali R&D Corporation
134 Old Washington St.
Hanover,  MA  02339
Applicant Contact JAN STANNARD
Correspondent
Denali R&D Corporation
134 Old Washington St.
Hanover,  MA  02339
Correspondent Contact JAN STANNARD
Regulation Number872.3765
Classification Product Code
EBC  
Date Received11/24/2008
Decision Date 01/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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