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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
Dong-A Pharmaceutical Co., Ltd.
64 Cheonho-daero, Dongdaemun-gu
Seoul,  KR 02587
Applicant Contact Hyunjeong Jang
Provision Consulting Group, Inc.
100 N. Barranca St. Suite 700
West Covina,  CA  91791
Correspondent Contact Joyce Kwon
Regulation Number884.5470
Classification Product Code
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