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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 K033665
Device Name VENUS FLOW
Applicant
Heraeus Kulzer, Inc.
4315 S. Lafayette Blvd.
South Bend,  IN  46614 -2517
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer, Inc.
4315 S. Lafayette Blvd.
South Bend,  IN  46614 -2517
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/21/2003
Decision Date 12/30/2003
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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