ELETONE CREAM— 510(k) K092297

Substantially Equivalent

Ferndale Pharma Group, Inc.

FDA 510(k) clearance K092297 for ELETONE CREAM, Substantially Equivalent on 2009-10-09. Applicant: Ferndale Pharma Group, Inc..

Clearance details

Applicant: Ferndale Pharma Group, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2009-07-29
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ferndale, MI, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.