The following data is part of a premarket notification filed by Keepers!, Inc. with the FDA for Gladrags Cotton Menstrual Pad.
| Device ID | K980395 |
| 510k Number | K980395 |
| Device Name: | GLADRAGS COTTON MENSTRUAL PAD |
| Classification | Pad, Menstrual, Unscented |
| Applicant | KEEPERS!, INC. 2110 N. WILLIAMS P O BOX 12648 Portland, OR 97212 |
| Contact | Brenda Mallory |
| Correspondent | Brenda Mallory KEEPERS!, INC. 2110 N. WILLIAMS P O BOX 12648 Portland, OR 97212 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1998-04-16 |