SURGICAL RETRACTORS-VARIOUS— 510(k) K841009

Substantially Equivalent

Premier Dental Products Co.

FDA 510(k) clearance K841009 for SURGICAL RETRACTORS-VARIOUS, Substantially Equivalent on 1984-05-01. Applicant: Premier Dental Products Co..

Clearance details

Applicant: Premier Dental Products Co.
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1984-03-09
Decision date: 1984-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.