First Quality Hygienic, Inc. · Class II · Cleared Nov 2, 2015
| K-number | K151470 |
| Device name | 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 |
| Applicant | First Quality Hygienic, Inc. |
| Product code | HEB |
| Device class | Class II |
| Decision date | Nov 2, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 884.5470 |
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