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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 K152284
Device Name COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
Applicant
COTTON HIGH TECH S.L.
Colonia La Rabeia s/n
Barcelona,  ES 08660
Applicant Contact Anna Garcia
Correspondent
COTTON HIGH TECH S.L.
Colonia La Rabeia s/n
Barcelona,  ES 08660
Correspondent Contact Anna Garcia
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/12/2015
Decision Date 12/04/2015
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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