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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K241927
Device Name Synthes Graphic Case & Tray System
Applicant
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Applicant Contact Thomas Shea
Correspondent
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Correspondent Contact Thomas Shea
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/01/2024
Decision Date 03/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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