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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K170725
Device Name Stryker Universal Mesh
Applicant
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Applicant Contact Jonathan Schell
Correspondent
Stryker
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Correspondent Contact Jonathan Schell
Regulation Number882.5320
Classification Product Code
GWO  
Date Received03/09/2017
Decision Date 11/13/2017
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
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