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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 K222046
Device Name Unscented Menstrual Tampon
Applicant
Suzhou Borage Medical Technology Co., Ltd.
#9, Shiheshan Rd., Dongshan Town, Wuzhong District
Suzhou,  CN 215107
Applicant Contact Zhou Nana
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 Received07/11/2022
Decision Date 09/30/2022
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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