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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, chin, internal
510(k) Number K191916
Device Name Stryker CMF MEDPOR Priority Customized Implant Kit
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 Number878.3550
Classification Product Code
FWP  
Date Received07/17/2019
Decision Date 08/15/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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