The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for 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 Applicato.
| Device ID | K161877 |
| 510k Number | K161877 |
| Device Name: | 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 Applicato |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | FIRST QUALITY HYGIENIC, INC. 121 NORTH RD. Mcelhattan, PA 17748 |
| Contact | Melanie Leibowitz |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-07-08 |
| Decision Date | 2016-08-05 |
| Summary: | summary |