The following data is part of a premarket notification filed by Tampax, Inc. with the FDA for Regular Maxithins Pads & Super Maxithins.
| Device ID | K821800 |
| 510k Number | K821800 |
| Device Name: | REGULAR MAXITHINS PADS & SUPER MAXITHINS |
| Classification | Pad, Menstrual, Unscented |
| Applicant | TAMPAX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-07 |
| Decision Date | 1982-06-25 |