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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 K112300
Device Name KIMGUARD SMART-FOLD* STERILIZATION WRAP
Applicant
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Bldg. 300
Roswell,  GA  30076
Applicant Contact Brenda Shelkey
Correspondent
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Bldg. 300
Roswell,  GA  30076
Correspondent Contact Brenda Shelkey
Regulation Number880.6850
Classification Product Code
FRG  
Date Received08/10/2011
Decision Date 01/19/2012
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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