J SINGLE USE HEAD AND JD REUSABLE HANDLE— 510(k) K950555

Substantially Equivalent

Micro-Mega Societe Anonyme

FDA 510(k) clearance K950555 for J SINGLE USE HEAD AND JD REUSABLE HANDLE, Substantially Equivalent on 1995-12-28. Applicant: Micro-Mega Societe Anonyme. Device class: 1.

Clearance details

Applicant
Micro-Mega Societe Anonyme
Product code
Code EGS
Device class
Class 1
Regulation
21 CFR 872.4200
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Besancon, FR
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EGS

product code EGS
Injury
356
Malfunction
759
Total
1,115

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.