The following data is part of a premarket notification filed by Paragon Trade Brands, Inc. with the FDA for Unscented Menstrual Shield.
| Device ID | K953487 |
| 510k Number | K953487 |
| Device Name: | UNSCENTED MENSTRUAL SHIELD |
| Classification | Pad, Menstrual, Unscented |
| Applicant | PARAGON TRADE BRANDS, INC. 33325 8TH AVENUE SOUTH Federal Way, WA 98003 |
| Contact | Tony Silwanoqicz |
| Correspondent | Tony Silwanoqicz PARAGON TRADE BRANDS, INC. 33325 8TH AVENUE SOUTH Federal Way, WA 98003 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-25 |
| Decision Date | 1995-08-09 |