DeviceClearance

K813030

Substantially Equivalent

O.R. ARMBOARD COVER

Applicant
Tecnol New Jersey Wound Care, Inc.
Product code
FWZ
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hammonton, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FWZ

product code FWZ
Malfunction
932
Other
1
Total
933

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.