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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 K110449
Device Name ENDOBON XENOGRAFT GRANULES
Applicant
BIOMET 3I
4555 RIVERSIDE DRIVE
PALM BEACH GARDENS,  FL  33410
Applicant Contact MARTHA I GARAY
Correspondent
BIOMET 3I
4555 RIVERSIDE DRIVE
PALM BEACH GARDENS,  FL  33410
Correspondent Contact MARTHA I GARAY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/16/2011
Decision Date 05/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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