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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K030052
Device Name OSTIM
Applicant
Heraeus Kulzer, Inc.
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer, Inc.
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/06/2003
Decision Date 12/06/2004
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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