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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Chemical
510(k) Number K252843
Device Name STERRAD 100NX Sterilization System with ALLClear Technology (10104)
Applicant
Advanced Sterilization Products, Inc.
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Brandon Roberts
Correspondent
Advanced Sterilization Products, Inc.
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Brandon Roberts
Regulation Number880.6860
Classification Product Code
MLR  
Date Received09/08/2025
Decision Date 04/15/2026
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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