Last synced on 14 November 2025 at 11:06 pm

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

Page Type
Cleared 510(K)
510(k) Number
K151470
510(k) Type
Abbreviated
Applicant
FIRST QUALITY HYGIENIC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2015
Days to Decision
154 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
510(k) Number
K151470
510(k) Type
Abbreviated
Applicant
FIRST QUALITY HYGIENIC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2015
Days to Decision
154 days
Submission Type
Summary