KOTEX SECURITY TAMPONS (SEVERAL TYPE)
FDA 510(k) clearance K896994 · decided 1989-12-22
Clearance details
- K-number
- K896994
- Device name
- KOTEX SECURITY TAMPONS (SEVERAL TYPE)
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-11
- Decision date
- 1989-12-22
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 coun recall (Z-0393-2012) | Kimberly-Clark Corporation | 2012-01-11 |