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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, cranioplasty, preformed, alterable
510(k) Number K121624
Device Name BIOMET MICROFIXATION NEURO PLATING SYSTEM
Original Applicant
BIOMET MICROFIXATION
1520 tradeport dr.
jacksonville,  FL  32218
Original Contact sheryl malmberg
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Codes
GXR   HBW  
Date Received06/01/2012
Decision Date 10/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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