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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 K151725
Device Name STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact SUN CHOI
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact SUN CHOI
Regulation Number880.6860
Classification Product Code
MLR  
Date Received06/26/2015
Decision Date 01/13/2016
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
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