The following data is part of a premarket notification filed by Hygieia Healthcare Ltd. with the FDA for Tampon, Untreated.
Device ID | K950194 |
510k Number | K950194 |
Device Name: | 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 | P Brenikov |
Correspondent | P 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 | 1995-01-18 |
Decision Date | 1995-08-25 |