SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE— 510(k) K851524

Substantially Equivalent

Specialites Septodont

FDA 510(k) clearance K851524 for SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE, Substantially Equivalent on 1985-09-23. Applicant: Specialites Septodont.

Clearance details

Applicant
Specialites Septodont
Product code
Code DZM
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Washington, DC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DZM

product code DZM
Injury
139
Total
139

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.