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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 K781375
Device Name COMFORM ABSORBANT INCONTINENCE PADS
Applicant
KIMBERLY-CLARK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
KIMBERLY-CLARK CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received08/09/1978
Decision Date 09/20/1978
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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