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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 K182425
Device Name Universal Mesh - Sterile
Applicant
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Applicant Contact Gregory Gohl
Correspondent
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg,  DE D-79111
Correspondent Contact Gregory Gohl
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Code
JEY  
Date Received09/06/2018
Decision Date 11/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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