The following data is part of a premarket notification filed by First Quality Hygienic Inc. with the FDA for Femtex And Private Label Opal Fresh Scented Plastic Applicator Tampons.
| Device ID | K051446 |
| 510k Number | K051446 |
| Device Name: | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | FIRST QUALITY HYGIENIC INC. 73 FRANKLIN TPK Allendale, NJ 07401 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab FIRST QUALITY HYGIENIC INC. 73 FRANKLIN TPK Allendale, NJ 07401 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-02 |
| Decision Date | 2005-07-14 |
| Summary: | summary |