SURGICAL DRESSINGS— 510(k) K812831

Substantially Equivalent

Foreign Trade Zone of Wisconsin

FDA 510(k) clearance K812831 for SURGICAL DRESSINGS, Substantially Equivalent on 1981-11-06. Applicant: Foreign Trade Zone of Wisconsin.

Clearance details

Applicant
Foreign Trade Zone of Wisconsin
Product code
Code GDY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GDY

product code GDY
Malfunction
764
Total
764

Source: openFDA MAUDE database, through . 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.