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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K080814
Device Name VOCO PROFLUORID VARNISH
Applicant
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE D-27472
Applicant Contact M.TH PLAUMANN
Correspondent
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE D-27472
Correspondent Contact M.TH PLAUMANN
Regulation Number872.3260
Classification Product Code
LBH  
Date Received03/24/2008
Decision Date 07/24/2008
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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