The following data is part of a premarket notification filed by Tosama, D.o.o. with the FDA for Tosama Biobased Applicator Tube Menstrual Tampon.
| Device ID | K172504 |
| 510k Number | K172504 |
| Device Name: | Tosama Biobased Applicator Tube Menstrual Tampon |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TOSAMA, D.o.o. Saranoviceva Cesta 35 Vir, SI 1230 |
| Contact | Marjetka Kralj Kuncic |
| Correspondent | Janez Obreza TOSAMA, D.o.o. Saranoviceva Cesta 35 Vir, SI 1230 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-18 |
| Decision Date | 2018-02-09 |
| Summary: | summary |