The following data is part of a premarket notification filed by Hygieia Healthcare Ltd. with the FDA for Non Applicator Tampon, Untreated.
| Device ID | K954445 |
| 510k Number | K954445 |
| Device Name: | NON APPLICATOR TAMPON, UNTREATED |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | HYGIEIA HEALTHCARE LTD. UNIT 2 SUNRISE ENTERPRISE PARK FERRYBOAT LANE Castletown, Sunderland Sr5 3rx, GB Sr5 3rx |
| Contact | Peter Brenikov |
| Correspondent | Peter Brenikov HYGIEIA HEALTHCARE LTD. UNIT 2 SUNRISE ENTERPRISE PARK FERRYBOAT LANE Castletown, Sunderland Sr5 3rx, GB Sr5 3rx |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1996-02-12 |