The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Super Plus Petal Soft Plastic Applicator Tampons.
| Device ID | K864648 |
| 510k Number | K864648 |
| Device Name: | SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab 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 | 1986-11-26 |
| Decision Date | 1987-03-04 |