The following data is part of a premarket notification filed by Tosama D.o.o. with the FDA for Tosama 100% Cotton Menstrual Tampon.
| Device ID | K150897 |
| 510k Number | K150897 |
| Device Name: | Tosama 100% Cotton Menstrual Tampon |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TOSAMA D.O.O. SARANOVICEVA CESTA 035 Vir, Domzale, SI 1230 |
| Contact | Marjetka Kralj Kuncic |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-04-20 |
| Summary: | summary |