Last synced on 14 November 2025 at 11:06 pm

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

Page Type
Cleared 510(K)
510(k) Number
K161877
510(k) Type
Special
Applicant
FIRST QUALITY HYGIENIC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/5/2016
Days to Decision
28 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
510(k) Number
K161877
510(k) Type
Special
Applicant
FIRST QUALITY HYGIENIC, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/5/2016
Days to Decision
28 days
Submission Type
Summary