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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 K040742
Device Name MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact KEVIN CORRIGAN
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact KEVIN CORRIGAN
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received03/23/2004
Decision Date 04/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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