Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl— 510(k) K161877
Substantially EquivalentFirst Quality Hygienic, Inc.
FDA 510(k) clearance K161877 for Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl, Substantially Equivalent on 2016-08-05. 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
- Special
- 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.