The following data is part of a premarket notification filed by Paragon Trade Brands, Inc. with the FDA for Menstrual Tampon.
| Device ID | K953333 |
| 510k Number | K953333 |
| Device Name: | MENSTRUAL TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PARAGON TRADE BRANDS, INC. 33325 8TH AVENUE SOUTH Federal Way, WA 98003 |
| Contact | Tony Silwanowicz |
| Correspondent | Tony Silwanowicz PARAGON TRADE BRANDS, INC. 33325 8TH AVENUE SOUTH Federal Way, WA 98003 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1995-12-06 |