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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tampon, menstrual, unscented
510(k) Number K981953
Device Name VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
Applicant
PARAGON TRADE BRANDS, INC.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Applicant Contact ROBERT J STAAB
Correspondent
PARAGON TRADE BRANDS, INC.
73 FRANKLIN TPK.
ALLENDALE,  NJ  07401
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received06/03/1998
Decision Date 08/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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