First Quality Hygienic, Inc. · Class II · Cleared Aug 5, 2016
| K-number | K161877 |
| Device name | 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 |
| Applicant | First Quality Hygienic, Inc. |
| Product code | HEB |
| Device class | Class II |
| Decision date | Aug 5, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 884.5470 |
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