SERIES XE, SERIES SE, SERIES TE— 510(k) K971350

Substantially Equivalent

Micro-Mega Societe Anonyme

FDA 510(k) clearance K971350 for SERIES XE, SERIES SE, SERIES TE, Substantially Equivalent on 1997-06-04. Applicant: Micro-Mega Societe Anonyme.

Clearance details

Applicant: Micro-Mega Societe Anonyme
Product code: Code EGS
Advisory panel: Dental
Date received: 1997-04-10
Decision date: 1997-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besancon, FR

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Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.