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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K113512
Device Name BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
Applicant
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact SHERYL MALMBERG
Correspondent
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact SHERYL MALMBERG
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
HWC  
Date Received11/28/2011
Decision Date 06/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
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