The following data is part of a premarket notification filed by Hospital Specialty Co. with the FDA for Gards (unscented, Menstrual Pad).
| Device ID | K822433 |
| 510k Number | K822433 |
| Device Name: | GARDS (UNSCENTED, MENSTRUAL PAD) |
| Classification | Pad, Menstrual, Unscented |
| Applicant | HOSPITAL SPECIALTY CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-12 |
| Decision Date | 1982-08-30 |