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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 K170773
Device Name Stryker Universal Mesh
Applicant
Stryker
750 Trade Centre Way - Suite 200
Portage,  MI  49002
Applicant Contact Gregory Gohl
Correspondent
Stryker
750 Trade Centre Way - Suite 200
Portage,  MI  49002
Correspondent Contact Gregory Gohl
Regulation Number872.4760
Classification Product Code
JEY  
Date Received03/14/2017
Decision Date 11/08/2017
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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