The following data is part of a premarket notification filed by Tosama D.o.o. with the FDA for Lil-lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus And Ultra Lil-lets Non Applicator,.
| Device ID | K120481 |
| 510k Number | K120481 |
| Device Name: | LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR, |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | TOSAMA D.O.O. SARANOVICEVA CESTA 035 Vir, Domzale, SI 1230 |
| Contact | Marjetka Kralj Kuncic |
| Correspondent | Marjetka Kralj Kuncic TOSAMA D.O.O. 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 | 2012-02-16 |
| Decision Date | 2012-07-13 |
| Summary: | summary |