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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 K234082
Device Name STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvine,  CA  92618
Applicant Contact Ayse Erkan
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvine,  CA  92618
Correspondent Contact Ayse Erkan
Regulation Number880.6860
Classification Product Code
MLR  
Subsequent Product Code
FRG  
Date Received12/22/2023
Decision Date 07/05/2024
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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