CSR— 510(k) K974865

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K974865 for CSR, Substantially Equivalent on 1998-03-16. Applicant: Parkell, Inc..

Clearance details

Applicant: Parkell, Inc.
Product code: Code EBI
Advisory panel: Dental
Date received: 1997-12-29
Decision date: 1998-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.