Youjia Unscented Tampon With Plastic Applicators

Tampon, Menstrual, Unscented

Qingdao Youjia Hygiene Technology Co., Ltd

The following data is part of a premarket notification filed by Qingdao Youjia Hygiene Technology Co., Ltd with the FDA for Youjia Unscented Tampon With Plastic Applicators.

Pre-market Notification Details

Device IDK192557
510k NumberK192557
Device Name:Youjia Unscented Tampon With Plastic Applicators
ClassificationTampon, Menstrual, Unscented
Applicant Qingdao Youjia Hygiene Technology Co., Ltd No. 778 Mingyue Road, Huangdao Zone Qingdao,  CN 266400
ContactHuiying Zhao
CorrespondentEmma Xing
Suzhou Jiuzhen Consulting Company Ltd. North Building, A1, 218, Xinghu Str., Suzhou Industrial Park Suzhou,  CN 215123
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-17
Decision Date2020-02-13

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