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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 K091084
Device Name MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
Applicant
COTTON HIGH TECH SL
CTRA NAVAS A PRATS DE LLUCANES
KM 1,5 GAIA
BARCELONA,  ES 08679
Applicant Contact ELENA GOMEZ
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/15/2009
Decision Date 04/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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