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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K163598
Device Name Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator
Applicant
Advanced Sterilization Products
33 Technology Dr.
Irvine,  CA  92612
Applicant Contact NAZANIN YACOBI
Correspondent
Advanced Sterilization Products
33 Technology Dr.
Irvine,  CA  92612
Correspondent Contact NAZANIN YACOBI
Regulation Number880.6850
Classification Product Code
KCT  
Subsequent Product Code
JOJ  
Date Received12/21/2016
Decision Date 07/31/2017
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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