Unscented W long plastic and cardboard applicator tampons
FDA 510(k) clearance K191666 · decided 2019-12-20
Clearance details
- K-number
- K191666
- Device name
- Unscented W long plastic and cardboard applicator tampons
- Applicant
- Ontex Bvba
- Decision
- Substantially Equivalent
- Date received
- 2019-06-21
- Decision date
- 2019-12-20
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Buggenhout Oost - Vlaanderen, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.