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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 K142782
Device Name KIMGUARD ONE-STEP Sterilization Wrap
Applicant
Kimberly-Clark Health Care
1400 Holcomb Bridge Road
Roswell,  GA  30076
Applicant Contact Thomas Kozma
Correspondent
Kimberly-Clark Health Care
1400 Holcomb Bridge Road
Roswell,  GA  30076
Correspondent Contact Thomas Kozma
Regulation Number880.6850
Classification Product Code
FRG  
Date Received09/26/2014
Decision Date 03/09/2015
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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