EAGLEVISION GELLANSERTS, MODEL REF 0040— 510(k) K053333

Substantially Equivalent

Eagle Vision, Inc.

FDA 510(k) clearance K053333 for EAGLEVISION GELLANSERTS, MODEL REF 0040, Substantially Equivalent on 2006-05-02. Applicant: Eagle Vision, Inc..

Clearance details

Applicant: Eagle Vision, Inc.
Product code: Code LZU
Advisory panel: Unknown
Date received: 2005-12-01
Decision date: 2006-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

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.