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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 K091635
Device Name VENUS DIAMOND FLOW
Applicant
HERAEUS KULZER, LLC
300 HERAEUS WAY
SOUTH BEND,  IN  46614
Applicant Contact CHERYL ZIMMERMAN
Correspondent
HERAEUS KULZER, LLC
300 HERAEUS WAY
SOUTH BEND,  IN  46614
Correspondent Contact CHERYL ZIMMERMAN
Regulation Number872.3765
Classification Product Code
EBC  
Subsequent Product Code
LBH  
Date Received06/04/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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