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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
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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