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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 K864649
Device Name REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS
Applicant
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Applicant Contact STAAB, PHD
Correspondent
TAMBRANDS, INC.
BRIDGE & SPRINGFIELD STREETS
PALMER,  MA  01069
Correspondent Contact STAAB, PHD
Regulation Number884.5470
Classification Product Code
HEB  
Date Received11/26/1986
Decision Date 03/04/1987
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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