The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Assure Natural Fit Tampon.
| Device ID | K812618 |
| 510k Number | K812618 |
| Device Name: | ASSURE NATURAL FIT TAMPON |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
| Contact | A.j. Huetteman |
| Correspondent | A.j. Huetteman PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-15 |
| Decision Date | 1981-10-02 |