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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K083234
Device Name KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
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 Number878.4370
Classification Product Code
KKX  
Date Received11/03/2008
Decision Date 03/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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