LYOFOAM C ODOR-ABSORBING DRESSING— 510(k) K864084

Substantially Equivalent for Some Indications

Acme United Corp.

FDA 510(k) clearance K864084 for LYOFOAM C ODOR-ABSORBING DRESSING, Substantially Equivalent for Some Indications on 1986-11-21. Applicant: Acme United Corp..

Clearance details

Applicant: Acme United Corp.
Product code: Code FRO
Advisory panel: Unknown
Date received: 1986-10-20
Decision date: 1986-11-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fairfield, CT, 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.