The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Femtex And Private Label Scented Plastic Applicator Tampons.
| Device ID | K050067 |
| 510k Number | K050067 |
| Device Name: | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401 |
| Contact | Robert J Staab, Ph.d. |
| Correspondent | Robert J Staab, Ph.d. FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE 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 | 2005-01-12 |
| Decision Date | 2005-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10748364500445 | K050067 | 000 |
| 10748364500428 | K050067 | 000 |
| 10041520039931 | K050067 | 000 |
| 10050428259181 | K050067 | 000 |
| 00050428298763 | K050067 | 000 |
| 10050428397197 | K050067 | 000 |
| 10084579122476 | K050067 | 000 |
| 10084579122483 | K050067 | 000 |
| 00719283200075 | K050067 | 000 |
| 00719283200112 | K050067 | 000 |
| 00748364101758 | K050067 | 000 |
| 00748364102007 | K050067 | 000 |
| 10748364500421 | K050067 | 000 |
| 10748364500442 | K050067 | 000 |