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 |