The following data is part of a premarket notification filed by Tosama D.d. with the FDA for Maxim Plastic Applicator & Non-applicator Tampons.
| Device ID | K080775 |
| 510k Number | K080775 |
| Device Name: | MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TOSAMA D.D. SARANOVICEVA CESTA 035 Vir, Domzale, SI 1230 |
| Contact | Antonija Vidensek |
| Correspondent | Harry Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2008-09-10 |
| Summary: | summary |