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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 K843404
Device Name MOLINEA INCONTINENT PAD
Applicant
Paul Hartmann Corp.
P.O. Box 1161
Greenwood,  SC  29646 -
Applicant Contact ROBERT L CRAWFORD
Correspondent
Paul Hartmann Corp.
P.O. Box 1161
Greenwood,  SC  29646 -
Correspondent Contact ROBERT L CRAWFORD
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received08/30/1984
Decision Date 10/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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