Last synced on 27 January 2023 at 11:04 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)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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