Callaly Tampliner— 510(k) K201003

Name: FDA 510(k) clearance K201003
Creator: U.S. Food and Drug Administration
Published: 2020-12-07

Substantially Equivalent

Calla Lily Personal Care, Ltd.

FDA 510(k) clearance K201003 for Callaly Tampliner, Substantially Equivalent on 2020-12-07. Applicant: Calla Lily Personal Care, Ltd.. Device class: 2.

Clearance details

Applicant: Calla Lily Personal Care, Ltd.
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 2020-04-16
Decision date: 2020-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Calla Lily Personal Care, Ltd.

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K212304 — Callaly Tampliner (super plus absorbency)2021-08-19
K211469 — Callaly Tampliner2021-06-10

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.