TOME'S #'S 1221,1222,1223,1314,6640,6642— 510(k) K791980

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K791980 for TOME'S #'S 1221,1222,1223,1314,6640,6642, Substantially Equivalent on 1979-10-04. Applicant: Edward Weck, Inc..

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1979-09-25
Decision date: 1979-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.