TAMPAX C PLASTIC TAMPONS, UNSCENTED
FDA 510(k) clearance K110669 · decided 2011-06-02
Clearance details
- K-number
- K110669
- Device name
- TAMPAX C PLASTIC TAMPONS, UNSCENTED
- Applicant
- The Procter & Gamble Co.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-09
- Decision date
- 2011-06-02
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.