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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 K251033
Device Name Unscented menstrual long applicator tampon; Unscented menstrual Compact 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 433018
Applicant Contact Guofeng Ou
Correspondent
Shanghai Jiushun Enterprise Management Tech Service Co., Ltd.
Rm. 1502,Baoan Bldg.,# 800 Dongfang Rd.
Shanghai,  CN 200122
Correspondent Contact Doris Chen
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/03/2025
Decision Date 08/13/2025
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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