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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Examination
510(k) Number K880385
Device Name KIMBERLY-CLARK PROFESSIONAL JACKET
Applicant
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Applicant Contact CYNTHIA E SMITH
Correspondent
Kimberly-Clark Corp.
1400 Holcomb Bridge Rd.
Roswell,  GA  30076
Correspondent Contact CYNTHIA E SMITH
Regulation Number880.6265
Classification Product Code
FME  
Date Received01/28/1988
Decision Date 02/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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