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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 K842618
Device Name SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
Applicant
TAMBRANDS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TAMBRANDS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/05/1984
Decision Date 07/26/1984
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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