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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.
Bldg. #3, #33 Jing You Rd., Jiangning District
Nanjing,  CN 211100
Applicant Contact Huan Wang
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, # 55 Shizhou Middle Rd.,
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
Predetermined Change
Control Plan Authorized		 No
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