The following data is part of a premarket notification filed by Tosama D.d. with the FDA for Moxie Plastic Applicator And Moxie Non-applicator Tampon.
| Device ID | K092054 |
| 510k Number | K092054 |
| Device Name: | MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TOSAMA D.D. SARANOVICEVA CESTA 035 Vir, Domzale, SI 1230 |
| Contact | Antonija Vidensek |
| Correspondent | Antonija Vidensek TOSAMA D.D. SARANOVICEVA CESTA 035 Vir, Domzale, SI 1230 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-07 |
| Decision Date | 2009-07-29 |
| Summary: | summary |