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
Other 510(k) Applications for this Company
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact