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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 K091685
Device Name KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
Applicant
Kimberly-Clark Corp.
172 Conductor Dr.
Dawsonville,  GA  30534
Applicant Contact LISA PEACOCK
Correspondent
Kimberly-Clark Corp.
172 Conductor Dr.
Dawsonville,  GA  30534
Correspondent Contact LISA PEACOCK
Regulation Number880.6850
Classification Product Code
FRG  
Date Received06/10/2009
Decision Date 09/03/2009
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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