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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K103218
Device Name STERRAD CHEMICAL INDICATOR STRIP
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 Number880.2800
Classification Product Code
JOJ  
Date Received11/01/2010
Decision Date 04/01/2011
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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