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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Menstrual, Unscented
510(k) Number K850033
Device Name KOTEX MAXI PADS
Applicant
KIMBERLY-CLARK CORP.
1201 PENNSYLVANIA AVENUE, N.W.
SUITE 730
WASHINGTON,  DC  20004
Applicant Contact BONNIE B WAN
Correspondent
KIMBERLY-CLARK CORP.
1201 PENNSYLVANIA AVENUE, N.W.
SUITE 730
WASHINGTON,  DC  20004
Correspondent Contact BONNIE B WAN
Regulation Number884.5435
Classification Product Code
HHD  
Date Received01/03/1985
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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