SILVER WOUND PAD— 510(k) K083659

Name: FDA 510(k) clearance K083659
Creator: U.S. Food and Drug Administration
Published: 2009-04-16

Substantially Equivalent

Milliken & Co.

FDA 510(k) clearance K083659 for SILVER WOUND PAD, Substantially Equivalent on 2009-04-16. Applicant: Milliken & Co.. Device class: Unclassified.

Clearance details

Applicant: Milliken & Co.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2008-12-10
Decision date: 2009-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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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.