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FDA 510(k) Application Details - K232598
Device Classification Name
Tampon, Menstrual, Unscented
More FDA Info for this Device
510(K) Number
K232598
Device Name
Tampon, Menstrual, Unscented
Applicant
Unibeauty (Hubei) Technology Co.,Ltd.
Building A8, nonwoven small and medium-sized enterprise
Industrial Park, PENGCHANG Town,
Xiantao 433018 CN
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Contact
Lin Fongshun
Other 510(k) Applications for this Contact
Regulation Number
884.5470
More FDA Info for this Regulation Number
Classification Product Code
HEB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/28/2023
Decision Date
12/15/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K232598
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