The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Femtex Gentle Touch Tampons.
| Device ID | K963034 |
| 510k Number | K963034 |
| Device Name: | FEMTEX GENTLE TOUCH TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| 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 | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1996-11-01 |
| Summary: | summary |