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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
Applicant
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE,  MI  49002
Applicant Contact JAMSHED BADARPURA
Correspondent
Stryker
750 TRADE CENTRE WAY
STE 200
PORTAGE,  MI  49002
Correspondent Contact JAMSHED BADARPURA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/24/2012
Decision Date 01/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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