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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 K092167
Device Name KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact THOMAS KOZMA
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact THOMAS KOZMA
Regulation Number880.6850
Classification Product Code
FRG  
Date Received07/21/2009
Decision Date 11/02/2009
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
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