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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(K) Number K121302
Device Name BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Applicant
BIOMET MICROFIXATION
1520 tradeport dr.
jacksonville,  FL  32218
Contact sheryl malmberg
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/13/2012
Decision Date 09/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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