The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Private Labels And Femtex.
| Device ID | K920238 |
| 510k Number | K920238 |
| Device Name: | PRIVATE LABELS AND FEMTEX |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401 |
| Contact | Robert Staab |
| Correspondent | Robert Staab FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-17 |
| Decision Date | 1993-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20024291271424 | K920238 | 000 |
| 00024291271420 | K920238 | 000 |