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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K111402
Device Name KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
Applicant
Kimberly-Clark
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact ANN WATERHOUSE, RAC
Correspondent
Kimberly-Clark
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact ANN WATERHOUSE, RAC
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/19/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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