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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gown, surgical
510(k) Number K103406
Device Name MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
BLDG 300, #1093
ROSWELL,  GA  30076 -2199
Applicant Contact DAVID M LEE
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number878.4040
Classification Product Code
FYA  
Date Received11/19/2010
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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