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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 K864859
Device Name SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS
Applicant
TAMBRANDS, INC.
bridge & springfield streets
palmer,  MA  01069
Applicant Contact davis, ph.d.
Correspondent
TAMBRANDS, INC.
bridge & springfield streets
palmer,  MA  01069
Correspodent Contact davis, ph.d.
Regulation Number884.5470
Classification Product Code
HEB  
Date Received12/11/1986
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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