The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Super Petal Soft Plastic Applicator Tampax Tampons.
| Device ID | K861910 |
| 510k Number | K861910 |
| Device Name: | SUPER PETAL SOFT PLASTIC APPLICATOR TAMPAX TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Staab, Phd |
| Correspondent | Staab, Phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-19 |
| Decision Date | 1986-08-12 |