510(k) K223749

U by Kotex® Click® Unscented Menstrual Tampons by Kimberly-Clark Corporation — Product Code HEB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 6, 2023
Date Received: December 14, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Tampon, Menstrual, Unscented
Device Class: Class II
Regulation Number: 884.5470
Review Panel: OB
Submission Type

An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

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