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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 K121589
Device Name BIOMET MICROFIXATION FACIAL PLATING SYSTEM
Applicant
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact LAUREN JASPER
Correspondent
BIOMET MICROFIXATION
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact LAUREN JASPER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received05/31/2012
Decision Date 09/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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