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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 K231341
Device Name Organic cotton tampon, Viscose tampon
Applicant
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.
Lianshi Industrial Park, Nanxun District
Huzhou,  CN 313013
Applicant Contact Roy Du
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number884.5470
Classification Product Code
HEB  
Date Received05/09/2023
Decision Date 08/14/2023
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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