INTRA-ORAL IRRIGATOR— 510(k) K933547

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K933547 for INTRA-ORAL IRRIGATOR, Substantially Equivalent on 1993-10-20. Applicant: Parkell, Inc..

Clearance details

Applicant: Parkell, Inc.
Product code: Code ELC
Advisory panel: Dental
Date received: 1993-07-22
Decision date: 1993-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.