COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS; COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS— 510(k) K152284

Clearance details

Device name as filed

COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS

Applicant

Cotton High Tech S.L.

Product code

Code HEB

Device class

Class 2

Regulation

21 CFR 884.5470

Advisory panel

Obstetrics/Gynecology

Date received

2015-08-12

Decision date

2015-12-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Barcelona, ES

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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 →