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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K994304
Device Name ARABESK FLOW
Applicant
Voco GmbH
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK
Correspondent
Voco GmbH
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/21/1999
Decision Date 02/07/2000
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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