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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 K111377
Device Name STERRAD(R) 100NX STERILIZER DUO CYCLE
Applicant
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Applicant Contact NANCY CHU
Correspondent
ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE,  CA  92618
Correspondent Contact NANCY CHU
Regulation Number880.6860
Classification Product Code
MLR  
Date Received05/16/2011
Decision Date 09/13/2012
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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