Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency— 510(k) K151470
Substantially EquivalentFirst Quality Hygienic, Inc.
FDA 510(k) clearance K151470 for Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency, Substantially Equivalent on 2015-11-02. Applicant: First Quality Hygienic, Inc..
Clearance details
- Applicant
- First Quality Hygienic, Inc.
- Product code
- Code HEB
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mcelhattan, PA, US
Adverse events under product code HEB
product code HEB- Injury
- 329
- Malfunction
- 5,647
- Total
- 5,976
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.