UNIPLAIN & UNICHROM— 510(k) K042287

Substantially Equivalent

United Medical Industries Co. , Ltd.

FDA 510(k) clearance K042287 for UNIPLAIN & UNICHROM, Substantially Equivalent on 2005-09-07. Applicant: United Medical Industries Co. , Ltd..

Clearance details

Applicant: United Medical Industries Co. , Ltd.
Product code: Code GAL
Advisory panel: General, Plastic Surgery
Date received: 2004-08-24
Decision date: 2005-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riyadh, Central Province, SA

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Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

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.