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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K113806
Device Name KIMGUARD ONE STEP STERILIZATION WRAP
Applicant
Kimberly-Clark Health Care
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact CHRISTOPHER B SWANSON
Correspondent
Kimberly-Clark Health Care
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact CHRISTOPHER B SWANSON
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/23/2011
Decision Date 08/20/2013
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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