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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 K212272
Device Name Tempo Natural Tampon
Applicant
Dong-A Pharmaceutical Co., Ltd.
64 Cheonho-Daero, Dongdaemun-Gu
Seoul,  KR 02587
Applicant Contact Hyunjeong Jang
Correspondent
Provision Consulting Group, Inc.
100 N Barranca St., Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number884.5470
Classification Product Code
HEB  
Date Received07/20/2021
Decision Date 09/17/2021
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
Predetermined Change
Control Plan Authorized		 No
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