KOTEX SECURITY TUBE TAMPONS
FDA 510(k) clearance K802193 · decided 1980-11-12
Clearance details
- K-number
- K802193
- Device name
- KOTEX SECURITY TUBE TAMPONS
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-10
- Decision date
- 1980-11-12
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.