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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 K250802
Device Name STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)
Applicant
Advanced Sterilization Products, Inc.
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Ayse Erkan
Correspondent
Advanced Sterilization Products, Inc.
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Ayse Erkan
Regulation Number880.6860
Classification Product Code
MLR  
Date Received03/14/2025
Decision Date 04/14/2025
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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