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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 K220238
Device Name Cohitech Cottonlock Tampons with Reusable Applicator
Applicant
Cotton High Tech S.L.
Colonia La Rabeia S/N
Balsareny,  ES 08660
Applicant Contact Anna Garcia Llado
Correspondent
Cotton High Tech S.L.
Colonia La Rabeia S/N
Balsareny,  ES 08660
Correspondent Contact Anna Garcia Llado
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/28/2022
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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