MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS— 510(k) K091084
Substantially EquivalentCotton High Tech S.L.
FDA 510(k) clearance K091084 for MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS, Substantially Equivalent on 2009-04-29. Applicant: Cotton High Tech S.L.. Device class: 2.
Clearance details
- 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barcelona, ES
Recent devices under product code HEB
view allMore clearances from Cotton High Tech S.L.
view all- K220238 — Cohitech Cottonlock Tampons with Reusable Applicator
- K211775 — Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
- K212479 — Cohitech Reusable Tampon Applicator
- K182813 — COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
- K152284 — COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS; COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
Adverse events under product code HEB
product code HEB- Injury
- 329
- Malfunction
- 5,647
- Total
- 5,976
Source: openFDA MAUDE database, through . 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.