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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 K160818
Device Name STERRAD® NX Sterilizer with ALLClear™ Technology
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvine,  CA  92617
Applicant Contact Jamie Byun
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvine,  CA  92617
Correspondent Contact Jamie Byun
Regulation Number880.6860
Classification Product Code
MLR  
Date Received03/24/2016
Decision Date 09/27/2016
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
Recalls CDRH Recalls
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