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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 K162007
Device Name STERRAD NX Sterilizer
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Nazanin Yacobi
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Nazanin Yacobi
Regulation Number880.6860
Classification Product Code
MLR  
Date Received07/20/2016
Decision Date 02/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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