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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 K182142
Device Name FEMME Applicator Tampon
Applicant
Jiangsu YOAI Technology co., Ltd.
Building No.3, No.33 Jing You Road, Jiangning District
Nanjing,  CN 211100
Applicant Contact Huan Wang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Room 1122, No. 55 Shizhou Middle Road,
Nanshan District
Shenzhen,  CN GD755
Correspondent Contact Field Fu
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/07/2018
Decision Date 08/28/2019
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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