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 |