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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K143661
Device Name DirectInject
Applicant
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Applicant Contact Nathan VanSweden
Correspondent
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Correspondent Contact Nathan VanSweden
Regulation Number882.5300
Classification Product Code
GXP  
Date Received12/23/2014
Decision Date 09/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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