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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 DRIVE
PALM BEACH GARDENS,  FL  33410
Applicant Contact TAMARA J NELSON
Correspondent
BIOMET 3I
4555 RIVERSIDE DRIVE
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
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