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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 K843401
Device Name RIA PANTY SHIELDS
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 Number884.5435
Classification Product Code
HHD  
Date Received08/30/1984
Decision Date 10/15/1984
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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