The following data is part of a premarket notification filed by Universal Health Care Products Canada, Inc. with the FDA for Sanitary Menstrual Napkin.
| Device ID | K875309 |
| 510k Number | K875309 |
| Device Name: | SANITARY MENSTRUAL NAPKIN |
| Classification | Pad, Menstrual, Unscented |
| Applicant | UNIVERSAL HEALTH CARE PRODUCTS CANADA, INC. 870 ELLINGHAM ST., POINTE CLAIRE Quebec H9r 3s4, CA |
| Contact | Glenn Awada |
| Correspondent | Glenn Awada UNIVERSAL HEALTH CARE PRODUCTS CANADA, INC. 870 ELLINGHAM ST., POINTE CLAIRE Quebec H9r 3s4, CA |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-03-14 |