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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 K212277
Device Name Tempo 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 04/21/2022
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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