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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K854378
Device Name DEPEND FITTED BRIEF
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Applicant Contact DER WAL
Correspondent
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL,  GA  30076
Correspondent Contact DER WAL
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received10/30/1985
Decision Date 12/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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