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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 K212174
Device Name STERRAD 100NX Sterilizer with ALLClear Technology
Applicant
Advanced Sterilization Products, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Summer Bowman
Correspondent
Advanced Sterilization Products, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Summer Bowman
Regulation Number880.6860
Classification Product Code
MLR  
Date Received07/12/2021
Decision Date 10/09/2021
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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