OIL EMULSION NON-ADHERING DRESSING— 510(k) K850126

Substantially Equivalent

Absorbent Cotton Co., Inc.

FDA 510(k) clearance K850126 for OIL EMULSION NON-ADHERING DRESSING, Substantially Equivalent on 1985-04-25. Applicant: Absorbent Cotton Co., Inc..

Clearance details

Applicant: Absorbent Cotton Co., Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1985-01-14
Decision date: 1985-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valley Park, MO, US

Download summary PDF View on FDA.gov ↗

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.