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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K111908
Device Name BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
Applicant
BIOMET MICROFIXATION, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact KIM REED
Correspondent
BIOMET MICROFIXATION, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact KIM REED
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received07/05/2011
Decision Date 11/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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