LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,— 510(k) K120481

Substantially Equivalent

Tosama, D.O.O.

FDA 510(k) clearance K120481 for LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,, Substantially Equivalent on 2012-07-13. Applicant: Tosama, D.O.O..

Clearance details

Applicant: Tosama, D.O.O.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2012-02-16
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Vir, Domzale, SI

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.