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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
510(k) Number K962953
Device Name DEODORANT PANTY SHIELD
Applicant
PARAGON TRADE BRANDS, INC.
10 COMMERCE DR.
GAFFNEY,  SC  29340
Applicant Contact TONY SILWANOWICZ
Correspondent
PARAGON TRADE BRANDS, INC.
10 COMMERCE DR.
GAFFNEY,  SC  29340
Correspondent Contact TONY SILWANOWICZ
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
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