The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for 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.
| Device ID | K151470 |
| 510k Number | K151470 |
| Device Name: | 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 |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | FIRST QUALITY HYGIENIC, INC. 121 North Road Mcelhattan, PA 17748 |
| Contact | Melanie Leibowitz |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-11-02 |
| Summary: | summary |