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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 K192557
Device Name Youjia Unscented Tampon with Plastic Applicators
Applicant
Qingdao Youjia Hygiene Technology Co., Ltd
No. 778 Mingyue Road, Huangdao Zone
Qingdao,  CN 266400
Applicant Contact Huiying Zhao
Correspondent
Suzhou Jiuzhen Consulting Company Ltd.
North Building, A1, 218, Xinghu Str., Suzhou Industrial Park
Suzhou,  CN 215123
Correspondent Contact Emma Xing
Regulation Number884.5470
Classification Product Code
HEB  
Date Received09/17/2019
Decision Date 02/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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