The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Regular Petal Soft Plastic Applicator.
| Device ID | K842619 |
| 510k Number | K842619 |
| Device Name: | REGULAR PETAL SOFT PLASTIC APPLICATOR |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TAMBRANDS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-05 |
| Decision Date | 1984-07-26 |