Last synced on 30 September 2022 at 11:05 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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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