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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 K253719
Device Name Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
Applicant
Unibeauty (Hubei) Technology Co., Ltd.
Bldg. A8, Nonwoven Small And Medium-Sized Enterprise
Industrial Park, Pengchang Town
Xiantao,  CN
Applicant Contact Zhou Guan
Correspondent
Unibeauty (Hubei) Technology Co., Ltd.
Bldg. A8, Nonwoven Small And Medium-Sized Enterprise
Industrial Park, Pengchang Town
Xiantao,  CN
Correspondent Contact Sandra Jiang
Regulation Number884.5470
Classification Product Code
HEB  
Date Received11/24/2025
Decision Date 12/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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