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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pediatric/child facemask
510(k) Number K103150
Device Name KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
Applicant
KIMBERLY-CLARK
1400 HOLCOMB BRIDGE ROAD
SUITE 1154, BLDG 300
ROSWELL,  GA  30076
Applicant Contact ANN WATERHOUSE
Correspondent
KIMBERLY-CLARK
1400 HOLCOMB BRIDGE ROAD
SUITE 1154, BLDG 300
ROSWELL,  GA  30076
Correspondent Contact ANN WATERHOUSE
Regulation Number878.4040
Classification Product Code
OXZ  
Date Received10/26/2010
Decision Date 09/23/2011
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
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