MASK, SURGICAL, DISP— 510(k) K770513

Substantially Equivalent

Acme Automatic Disposable

FDA 510(k) clearance K770513 for MASK, SURGICAL, DISP, Substantially Equivalent on 1977-04-29. Applicant: Acme Automatic Disposable.

Clearance details

Applicant: Acme Automatic Disposable
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1977-03-17
Decision date: 1977-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.