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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 K220404
Device Name STERRAD NX with ALLClear Technology
Applicant
Advanced Sterilization Products, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Katy Nennig
Correspondent
Advanced Sterilization Products, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Katy Nennig
Regulation Number880.6860
Classification Product Code
MLR  
Date Received02/14/2022
Decision Date 05/16/2022
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
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