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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 K953666
Device Name UNSCENTED MENSTRAL PAD WITH WINGS
Applicant
Paragon Trade Brands, Inc.
33325 8th Ave. S.
Federal Way,  WA  98003
Applicant Contact TONY SILWANOWICZ
Correspondent
Paragon Trade Brands, Inc.
33325 8th Ave. S.
Federal Way,  WA  98003
Correspondent Contact TONY SILWANOWICZ
Regulation Number884.5435
Classification Product Code
HHD  
Date Received08/07/1995
Decision Date 09/27/1995
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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