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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 K121235
Device Name LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
Original Applicant
STRYKER
750 trade centre way
ste 200
portage,  MI  49002
Original Contact jamshed badarpura
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/24/2012
Decision Date 01/09/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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