Tempo Tampon

Tampon, Menstrual, Unscented

Dong-A Pharmaceutical Co., Ltd.

The following data is part of a premarket notification filed by Dong-a Pharmaceutical Co., Ltd. with the FDA for Tempo Tampon.

Pre-market Notification Details

Device IDK212277
510k NumberK212277
Device Name:Tempo Tampon
ClassificationTampon, Menstrual, Unscented
Applicant Dong-A Pharmaceutical Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu Seoul,  KR 02587
ContactHyunjeong Jang
CorrespondentJoyce Kwon
Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina,  CA  91791
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-20
Decision Date2022-04-21

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