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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 K190218
Device Name Unscented Menstrual Tampon
Applicant
Qingdao Youjia Hygiene Technology Co., Ltd.
# 778 Mingyue Rd., Huangdao Zone
Qingdao,  CN 266400
Applicant Contact Huiying Zhao
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, # 55 Shizhou Middle Rd.,
Nanshan District
Shenzhen,  CN GD755
Correspondent Contact Jessie You
Regulation Number884.5470
Classification Product Code
HEB  
Date Received02/04/2019
Decision Date 05/09/2019
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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