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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, Scented, Scented-Deodorized
510(k) Number K962962
Device Name DEODORANT PANTY LINER
Applicant
Paragon Trade Brands, Inc.
10 Commerce Dr.
Gaffney,  SC  29340
Applicant Contact TONY S ILWANOWICZ
Correspondent
Paragon Trade Brands, Inc.
10 Commerce Dr.
Gaffney,  SC  29340
Correspondent Contact TONY S ILWANOWICZ
Regulation Number884.5425
Classification Product Code
HHL  
Date Received07/30/1996
Decision Date 10/10/1996
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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