The following data is part of a premarket notification filed by Tampax, Inc. with the FDA for Petal Soft Plastic Applicator Tampax.
| Device ID | K802760 |
| 510k Number | K802760 |
| Device Name: | PETAL SOFT PLASTIC APPLICATOR TAMPAX |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TAMPAX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-05 |
| Decision Date | 1981-01-12 |