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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K252307
Device Name Getinge GSS67N Series Steam Sterilizer
Applicant
Maquet GmbH (A Getinge Group Company)
Kehler Strasse 31
Rastatt De-Bw,  DE 76437
Applicant Contact Silke Avieny
Correspondent
Getinge
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Barb Smith
Regulation Number880.6880
Classification Product Code
FLE  
Date Received07/24/2025
Decision Date 01/22/2026
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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