Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
FDA 510(k) clearance K251033 · decided 2025-08-13
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-03
- Decision date
- 2025-08-13
- Days to decision
- 132 days
- Clearance type
- Special
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Xiantao, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.