FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
FDA 510(k) clearance K032173 · decided 2003-09-03
Clearance details
- K-number
- K032173
- Device name
- FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
- Applicant
- First Quality Hygienic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-16
- Decision date
- 2003-09-03
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- HIL
- Device class
- 2
- Regulation number
- 884.5460
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.