HOLE CHAMFERING DEVICE— 510(k) K841298

Substantially Equivalent

Techmedica, Inc.

FDA 510(k) clearance K841298 for HOLE CHAMFERING DEVICE, Substantially Equivalent on 1984-04-25. Applicant: Techmedica, Inc..

Clearance details

Applicant
Techmedica, Inc.
Product code
Code GFF
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 GFF

product code GFF
Malfunction
459
Other
1
Total
460

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.