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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, Human Source
510(k) Number K070147
Device Name INTERGRO ORAL
Applicant
Biomet 3i
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact TAMARA J NELSON
Correspondent
Biomet 3i
4555 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact TAMARA J NELSON
Regulation Number872.3930
Classification Product Code
NUN  
Date Received01/16/2007
Decision Date 05/14/2007
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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