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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 K132519
Device Name STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
Applicant
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Applicant Contact ROB YAMASHITA
Correspondent
Stryker
750 Trade Centre Way
Suite 200
Portage,  MI  49002
Correspondent Contact ROB YAMASHITA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/12/2013
Decision Date 12/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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