The following data is part of a premarket notification filed by Hygieia Healthcare Ltd. with the FDA for Tampon, Untreated.
| Device ID | K912941 |
| 510k Number | K912941 |
| Device Name: | TAMPON, UNTREATED |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | HYGIEIA HEALTHCARE LTD. RAINTON BRIDGE INDUS.ESTATE HOUGHTON-LE-SPRING Tyne And Wear, England, GB Dh4 5ph |
| Contact | Brenikov |
| Correspondent | Brenikov HYGIEIA HEALTHCARE LTD. RAINTON BRIDGE INDUS.ESTATE HOUGHTON-LE-SPRING Tyne And Wear, England, GB Dh4 5ph |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-01 |
| Decision Date | 1992-03-06 |