ONTEX TAMPON (UNSCENTED)
FDA 510(k) clearance K090819 · decided 2009-12-23
Clearance details
- K-number
- K090819
- Device name
- ONTEX TAMPON (UNSCENTED)
- Applicant
- Ontex International NV
- Decision
- Substantially Equivalent
- Date received
- 2009-03-25
- Decision date
- 2009-12-23
- Days to decision
- 273 days
- Clearance type
- Abbreviated
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.