84E SERIES SINGLE PLY WRAPPER— 510(k) K102864

Substantially Equivalent

Lac Mac, Ltd.

FDA 510(k) clearance K102864 for 84E SERIES SINGLE PLY WRAPPER, Substantially Equivalent on 2011-01-14. Applicant: Lac Mac, Ltd..

Clearance details

Applicant: Lac Mac, Ltd.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2010-09-30
Decision date: 2011-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.