ORAL PROCEDURE PACK— 510(k) K950743

Unknown

Transidyne General Corp.

FDA 510(k) clearance K950743 for ORAL PROCEDURE PACK, Unknown on 1995-03-31. Applicant: Transidyne General Corp..

Clearance details

Applicant: Transidyne General Corp.
Product code: Code EGS
Advisory panel: Dental
Date received: 1995-02-17
Decision date: 1995-03-31
Decision: Unknown
Clearance type: Traditional
Location: Spartanburg, SC, US

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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.